After a Hip Fracture in an Older Adult, Is Hemiarthroplasty or Total Hip Replacement the Better Choice?
Displaced femoral neck fracture in an older adult: how pre-fracture mobility, medical fitness, HEALTH trial and meta-analysis evidence, guidelines and bipolar head selection guide hemiarthroplasty versus total hip replacement.
She was walking independently yesterday. Today, she needs hip surgery.
A 79-year-old woman slips on her way to the bathroom at night.
She lands on her left side and immediately feels severe pain in her hip. She tries to get up but cannot put weight on the injured leg.
Her husband calls for an ambulance.
At the hospital, radiographs show a displaced femoral neck fracture.
Until the fall, she had been living at home, shopping independently and taking short walks in her neighborhood. She had hypertension and osteoporosis, but she managed her daily activities without help.
Her orthopedic surgeon explains that joint replacement is likely to offer a more reliable reconstruction than fixing this particular fracture with screws.
The family is surprised to hear that there are two possible operations.
One replaces the broken femoral head and leaves the natural hip socket in place. The other replaces both sides of the joint.
Her son asks why the socket would need replacing when it was not broken.
That question gets to the heart of the decision.
The surgeon is treating a fracture, but the choice of reconstruction also depends on the patient's health, previous mobility and what she is likely to need from the hip in the years ahead.
Clinical scenario: This is an illustrative composite patient representing a common hip-fracture consultation. Her age, medical history and circumstances are hypothetical. The case does not describe a verified AK Medical patient or clinical outcome.
Is hemiarthroplasty or total hip replacement better after a displaced femoral neck fracture?
Both are established operations for displaced intracapsular femoral neck fractures in older adults.
Hemiarthroplasty replaces the femoral head while retaining the natural acetabulum. Total hip arthroplasty (THA) replaces both the femoral head and the acetabular articular surface.
THA may be considered for patients who were independently mobile before the fracture, are medically suitable and are expected to maintain independent daily activities. Hemiarthroplasty remains a well-established choice for many patients, particularly when a less extensive reconstruction better suits their circumstances.
Age matters, but it should not make the decision on its own.
Why displaced femoral neck fractures are different
The femoral neck connects the femoral head to the upper femur.
A fracture through this area can interrupt blood supply to the femoral head. When the fragments are displaced, healing after internal fixation may be unreliable, particularly in older patients.
Nonunion and osteonecrosis are recognized risks.
This is why surgeons often recommend arthroplasty for displaced intracapsular fractures in older adults rather than attempting to preserve the fractured femoral head.
The American Academy of Orthopaedic Surgeons (AAOS) recommends arthroplasty over internal fixation for unstable or displaced femoral neck fractures.
NICE, the UK's National Institute for Health and Care Excellence, likewise recommends offering replacement arthroplasty to patients with displaced intracapsular hip fractures.
These recommendations are specific to the fracture pattern.
An undisplaced femoral neck fracture may be managed differently. Trochanteric fractures involve another anatomical region and often require a different fixation strategy.
The first step, therefore, is to identify the injury correctly.
The second is to understand the person who sustained it.
For the woman in our example, the fact that she was walking outdoors independently before the fall is important. So is her medical fitness and the condition of her natural hip socket.
What does each operation actually replace?
Hemiarthroplasty removes the fractured femoral head and replaces it with a prosthetic head attached to a femoral stem.
The natural acetabulum remains.
In a total hip replacement, the surgeon also prepares the acetabulum and implants a prosthetic cup and bearing.
That additional acetabular reconstruction changes both the procedure and the possible complications.
| Clinical consideration | Hemiarthroplasty | Total hip arthroplasty |
|---|---|---|
| Femoral head | Replaced | Replaced |
| Natural acetabulum | Retained | Replaced with an acetabular component |
| Extent of reconstruction | Primarily the femoral side | Femoral and acetabular sides |
| Common patient-selection considerations | Many older patients with a suitable natural socket | Selected independently mobile, medically suitable patients |
| Longer-term concern | Potential symptomatic acetabular erosion | Acetabular-component complications and instability |
| Operative considerations | Generally a less extensive joint reconstruction | Additional acetabular preparation and implantation |
The distinction matters because the natural socket may still be healthy.
If a patient had little or no hip pain before the fracture and the acetabular cartilage remains satisfactory, preserving the socket may be reasonable.
But the natural acetabulum is not guaranteed to remain symptom-free indefinitely.
Some patients develop acetabular erosion after hemiarthroplasty, particularly over longer periods of use.
Total hip replacement avoids articulation against the native acetabular cartilage but introduces a prosthetic cup and its associated risks.
The decision involves the entire patient, not just the appearance of the joint on an X-ray.
What do international guidelines recommend?
NICE provides one of the clearest clinical frameworks for this decision.
Its hip-fracture guideline, CG124, was updated in January 2023.
For patients with displaced intracapsular hip fractures, NICE advises considering total hip replacement rather than hemiarthroplasty when the patient:
-
Could walk outdoors independently before the fracture, using no more than a walking stick.
-
Has no medical condition or comorbidity that makes total hip replacement unsuitable.
-
Is expected to remain independently capable of daily activities for more than two years.
These are considerations for selecting patients likely to benefit from THA, not a guarantee that every patient meeting them should receive it.
The woman's previous independence makes THA a reasonable possibility.
Her medical condition, expected recovery and operative risks still need to be assessed.
AAOS guidance reaches a broadly similar conclusion. Total hip replacement may provide functional benefits in appropriately selected patients, but complications may also increase.
The guidelines leave room for the surgeon and patient to make a decision based on clinical circumstances.
Sources: NICE CG124 and AAOS Management of Hip Fractures in Older Adults [1, 2].
What happened to patients in the HEALTH trial?
The family would like to know whether one operation is more likely to require another procedure.
The HEALTH trial provides an important answer.
Published in The New England Journal of Medicine in 2019, it randomized 1,495 patients aged 50 or older who had displaced femoral neck fractures.
The study took place at 80 centers in ten countries.
Participants had been able to walk without another person's assistance before the fracture.
Researchers followed patients for 24 months, with the primary outcome being an unplanned secondary hip procedure.
Clinical Evidence 1 — HEALTH Randomized Trial
Study: HEALTH Investigators, 2019
Journal: The New England Journal of Medicine
DOI: 10.1056/NEJMoa1906190
PMID: 31557429
| Outcome at 24 months | Total hip arthroplasty | Hemiarthroplasty |
|---|---|---|
| Patients in the primary-outcome analysis | 718 | 723 |
| Unplanned secondary hip procedures | 57 (7.9%) | 60 (8.3%) |
| Hip instability or dislocation | 34 (4.7%) | 17 (2.4%) |
| Mortality | 14.3% | 13.1% |
| Serious adverse events | 41.8% | 36.7% |
Primary-outcome hazard ratio: 0.95
95% confidence interval: 0.64–1.40
P value: 0.79
Original research: PubMed | DOI
At two years, there was no statistically significant difference in the primary outcome of secondary hip procedures.
Function and some quality-of-life measures modestly favored total hip replacement.
Hip instability or dislocation was reported more often in the THA group, although the study's uncertainty around that comparison should be considered.
The findings are useful precisely because neither operation emerged as the obvious winner across every outcome.
THA offered some functional benefits, but those benefits were not large enough to support its routine use for every patient.
Hemiarthroplasty avoided replacing the socket but was not free of later complications or secondary procedures.
The study randomized 1,495 patients; the table reports the 1,441 patients included in the primary-outcome analysis. These are different denominators and should not be interchanged.
The HEALTH trial compared surgical treatment strategies. It did not evaluate the clinical performance of AK Medical AK-Bipolar or the other manufacturers discussed below.
What can we learn from 16 randomized trials?
The HEALTH trial was subsequently included in a broader systematic review.
In 2020, Ekhtiari and colleagues analyzed 16 randomized controlled trials comparing THA with hemiarthroplasty for displaced femoral neck fractures.
The review involved 3,084 participants.
Because some of its evidence comes from HEALTH, the two studies should not be counted as separate patient populations.
Clinical Evidence 2 — Randomized-Trial Meta-Analysis
Study: Ekhtiari et al., 2020
Journal: The Journal of Bone and Joint Surgery — American Volume
DOI: 10.2106/JBJS.20.00226
PMID: 32732709
| Study measure | Reported finding |
|---|---|
| Randomized trials | 16 |
| Total participants | 3,084 |
| Allocated to THA | 1,521 |
| Allocated to hemiarthroplasty | 1,563 |
| Mean quality-of-life difference favoring THA | 0.05 |
| 95% confidence interval | 0.02–0.07 |
| Prespecified threshold for a clinically important difference | 0.145 |
| Mean operative-time difference | 22 minutes shorter with hemiarthroplasty |
Original research: PubMed | DOI
Across the included randomized trials, the review did not identify a clear difference in revision outcomes within five years or functional outcomes within three years.
The average quality-of-life result favored THA, but the difference was smaller than the threshold the authors used for clinical importance.
Hemiarthroplasty had a shorter operating time on average.
The findings do not show that the procedures are identical.
They show that, across the studied populations, the average advantages of one procedure were not consistently large enough to make it preferable for all patients.
That matters when a family is deciding between two reasonable treatments.
For an active older adult who is expected to remain independent for years, the possible longer-term advantages of THA may carry weight.
For a patient with more limited mobility or substantial medical concerns, the shorter and less extensive reconstruction associated with hemiarthroplasty may be relevant.
Neither consideration should be used without assessing the patient's actual circumstances.
Why medical fitness matters as much as the implant
Hip fractures often occur in people who have other health conditions.
Heart disease, respiratory illness, frailty, cognitive impairment and reduced physiological reserve may all affect treatment planning.
Hemiarthroplasty generally avoids acetabular preparation and implantation. The randomized-trial meta-analysis found that its operating time was shorter on average.
But shorter surgery does not automatically mean a safer operation for every patient.
Anesthesia, blood loss, fixation method, bone quality and postoperative complications all need attention.
The multidisciplinary care pathway is equally important.
Hip-fracture treatment involves pain control, medical assessment, prevention of delirium and thromboembolism, early mobilization and rehabilitation.
NICE recommends surgery on the day of injury or the following day, while AAOS guidance notes that surgery within 24–48 hours may be associated with better outcomes.
Appropriate optimization is necessary, but avoidable delays are not helpful.
The woman's family is understandably focused on which implant she will receive.
Her recovery will also depend on the medical and rehabilitation support around the operation.
Why the choice of femoral fixation matters
Hemiarthroplasty and total hip replacement both require the surgeon to reconstruct the femoral side of the joint.
The femoral stem must achieve appropriate fixation in the remaining bone.
For hip fractures in older adults, cemented and cementless fixation have different considerations.
NICE recommends cemented implants for arthroplasty performed for displaced intracapsular fractures.
AAOS also recommends cemented femoral stems for arthroplasty in this population.
These recommendations reflect the available evidence, but cementation requires established safety precautions.
Bone cement implantation syndrome
Bone cement implantation syndrome (BCIS) is a recognized perioperative complication associated with cemented arthroplasty.
It can involve hypoxia and hypotension, with cardiovascular collapse in severe cases.
The risk requires coordination between the surgical and anesthesia teams, particularly in vulnerable patients.
This does not mean cemented stems should be avoided routinely. Instead, the recommended fixation strategy should be carried out with appropriate assessment and safeguards.
The exact implant selected must also be suitable for the intended fixation method.
A manufacturer's availability of cemented and cementless stems does not establish that all its components are indicated or authorized for hip-fracture arthroplasty in every market.
What is a bipolar hemiarthroplasty head?
If the surgeon and patient choose hemiarthroplasty, the next question is which components are suitable.
One option is a bipolar head.
A bipolar hemiarthroplasty assembly has two articulating interfaces.
The inner articulation is between the femoral head and a polyethylene bearing. The outer surface of the bipolar head articulates against the patient's natural acetabulum.
The concept differs from conventional total hip replacement, where an acetabular implant replaces the natural socket surface.
It also differs from a dual-mobility total hip system, which includes a prosthetic acetabular component.
Those distinctions are important when discussing implants with patients and when evaluating product catalogues.
Is a bipolar head necessarily better than a unipolar head?
No.
AAOS guidance indicates that unipolar and bipolar hemiarthroplasty can provide similar benefits in the relevant older hip-fracture population.
A bipolar head should therefore not be described as clinically superior simply because it incorporates an additional articulation.
Implant selection depends on patient factors, the complete reconstructive system and the available evidence.
Where AK Medical's AK-Bipolar fits
AK Medical includes AK-Bipolar in its published hip implant portfolio.
The company's product catalogue identifies a cobalt–chromium–molybdenum outer component and an ultra-high-molecular-weight polyethylene (UHMWPE) liner.
The catalogue also describes a locking mechanism and configurations designed to accommodate specified 22 mm and 28 mm femoral head sizes.
These are documented product characteristics. [5]
The catalogue provides a useful starting point for hospitals evaluating bipolar hemiarthroplasty components.
It does not establish that AK-Bipolar has lower dislocation rates, less acetabular wear or longer survivorship than other bipolar systems.
Those claims would require relevant product-specific evidence.
A bipolar head is only part of the reconstruction
The surgeon must also select an appropriate femoral stem and femoral head.
The selected components need to work together as an authorized implant construct.
Nominal head diameter alone is not enough to establish compatibility.
The appropriate taper, femoral head, neck length, bipolar assembly and fixation method must be verified against the manufacturer's current instructions.
The surgeon also needs to restore suitable leg length, offset and stability.
For hospitals considering AK-Bipolar, this is where technical evaluation becomes more meaningful than simply comparing the outer head's design.
Documents worth requesting
Before a product is considered for clinical use, a hospital should review the current instructions for use, compatible stem and head combinations, component sizes, instruments, clinical evidence and regulatory documentation.
For older patients undergoing hemiarthroplasty, the proposed stem-fixation strategy should also be evaluated against applicable clinical guidelines.
AK Medical product information:
https://www.ak-medical-global.com/products/acetabular-cup-system
How does AK-Bipolar compare with Stryker and DePuy Synthes?
Hospitals evaluating bipolar hemiarthroplasty systems may encounter products from several international manufacturers.
AK Medical's AK-Bipolar, Stryker's UHR Universal Head Bipolar System and DePuy's Self-Centering Bi-Polar Head are examples of documented bipolar head product families.
They can be compared on design and compatibility, but not on assumed clinical superiority.
International Bipolar Hemiarthroplasty System Comparison
| Evaluation area | AK Medical — AK-Bipolar | Stryker — UHR Universal Head Bipolar | DePuy Synthes — Self-Centering Bi-Polar |
|---|---|---|---|
| Product category | Bipolar hemiarthroplasty head | Bipolar hemiarthroplasty head system | Bipolar hemiarthroplasty head |
| Documented design | Metal outer component with polyethylene inner bearing | Manufacturer-described bipolar head with locking design | Self-centering bipolar head assembly |
| Publicly identified materials | Co-Cr-Mo outer component and UHMWPE liner | Verify materials for the exact current UHR model | Verify materials for the exact current model |
| Published inner head options | 22 mm and 28 mm families | Configuration-specific; verify current documentation | Model records include approximately 22.2 mm and 28 mm inner-diameter families |
| Principal technical consideration | Authorized head, stem and bipolar component combinations | Approved UHR component compatibility | Approved Self-Centering component compatibility |
| Essential documents | Current IFU, implant compatibility and applicable regulatory records | Current IFU, model configurations and regulatory records | Current IFU, model configurations and regulatory records |
Sources: AK Medical official catalogue; Stryker UHR surgical documentation; DePuy Self-Centering device records. [5–7]
The table identifies product design categories and available technical information.
It does not rank the systems.
Stryker's UHR includes a manufacturer-described locking and articulation design.
DePuy's Self-Centering bipolar components are identifiable through public device records, including model-specific inner and outer diameter information.
AK-Bipolar has a documented metal-and-polyethylene architecture with specified compatible head-size families.
None of these observations establishes which manufacturer achieves better clinical outcomes.
A device record also does not, on its own, confirm that a particular configuration remains available or authorized in every country.
For a hospital, the useful comparison concerns the complete reconstructive system: component compatibility, femoral fixation, available sizes, instruments, clinical evidence, staff familiarity and supply reliability.
What this means for AK Medical
AK Medical has a documented bipolar head option within its wider hip reconstruction portfolio.
That makes AK-Bipolar relevant to professional evaluation in hip fracture arthroplasty.
However, the HEALTH trial and the randomized-trial meta-analysis cannot be used as evidence of AK-Bipolar's own clinical performance.
Similarly, a manufacturer-described locking mechanism should not be promoted as preventing dislocation without appropriate supporting evidence.
An internationally credible product assessment should distinguish the principles of hemiarthroplasty from the evidence available for each specific implant.
Product regulatory status must be verified by model and market
Medical device authorization applies to specific products and jurisdictions.
It cannot be inferred from approvals held by another product manufactured by the same company.
AK Medical's product catalogue includes regulatory designations for its hip portfolio, including AK-Bipolar-related information.
Those designations are not a substitute for obtaining the current certificate applicable to the exact implant models.
Before procurement or clinical use, hospitals and distributors should verify the registered product name, component list, intended purpose, instructions for use and validity of the relevant authorization.
This article does not assert that AK-Bipolar is FDA-cleared or that every AK-Bipolar configuration is authorized throughout Europe or other international markets.
Any market-specific product claim must be supported by the applicable official documentation.
What should the family ask before surgery?
The woman's son now understands why the two operations are being considered.
His mother's independence before the fall makes total hip replacement worth discussing. Her health, acetabular condition and anticipated recovery will help determine whether it is the better choice.
Hemiarthroplasty remains a reasonable possibility if it matches her clinical needs.
The family can ask the surgeon four useful questions:
-
What makes this fracture more suitable for replacement than internal fixation?
-
How does her mobility before the fracture influence the choice between hemiarthroplasty and THA?
-
What are the main risks of the proposed operation, including dislocation and the possibility of another procedure?
-
What is the plan for mobilization and rehabilitation afterward?
These questions are more helpful than asking which implant is the newest.
The objective is to give her a stable hip reconstruction and the best reasonable opportunity to regain mobility.
The operation matters, but so do the patient's baseline health, timely care and rehabilitation.
Frequently Asked Questions
Why do older patients with displaced femoral neck fractures often receive hip replacement?
Displacement can compromise the blood supply to the femoral head and increase the risks of nonunion or osteonecrosis after fixation. Arthroplasty is an established treatment for suitable older patients.
What is the difference between hemiarthroplasty and total hip replacement?
Hemiarthroplasty replaces the femoral head while retaining the natural acetabulum. Total hip replacement replaces both the femoral head and the acetabular articular surface.
Can a 79-year-old patient receive total hip replacement after a fracture?
Yes. Age alone is not a contraindication. Pre-fracture mobility, medical fitness, expected independence and other clinical findings help determine suitability.
Is total hip replacement more likely to dislocate?
In the HEALTH trial, hip instability or dislocation was reported in 4.7% of the THA group and 2.4% of the hemiarthroplasty group at two years. Individual risk varies, and the numerical comparison should be interpreted with the study's confidence intervals and patient selection in mind.
Does hemiarthroplasty preserve the natural hip socket?
Yes. The natural acetabulum remains. Its cartilage may, however, develop wear or erosion over time in some patients.
Is a bipolar head better than a unipolar head?
Not necessarily. AAOS guidance indicates that both designs can provide similar benefits in older patients with displaced femoral neck fractures.
Is bipolar hemiarthroplasty the same as dual-mobility total hip replacement?
No. Bipolar hemiarthroplasty retains the natural acetabulum. A dual-mobility total hip replacement includes an implanted acetabular component.
Are cemented stems recommended for older hip-fracture patients?
NICE recommends cemented implants for arthroplasty in displaced intracapsular fractures. Clinical teams must also assess cement-related risks and follow appropriate safety procedures.
Does AK Medical offer a bipolar head system?
Yes. AK Medical lists AK-Bipolar in its official product catalogue. Current configurations, compatible components and regulatory status should be verified with the manufacturer.
How should hospitals compare bipolar systems from different manufacturers?
They should review component compatibility, approved indications, femoral fixation options, instruments, product-specific clinical evidence, regulatory documentation and supply arrangements.
Conclusion
A displaced femoral neck fracture can turn an independent older adult into a hospital patient overnight.
For the surgeon, the choice between hemiarthroplasty and total hip replacement is a balance between reconstructing enough of the joint and avoiding an unnecessary burden.
A patient who was active and independent before the fracture may benefit from consideration of total hip replacement.
Another patient may be better served by hemiarthroplasty, particularly when the natural acetabulum is satisfactory and the overall circumstances favor a less extensive reconstruction.
The HEALTH trial found similar rates of unplanned secondary hip procedures at two years. Its functional outcomes modestly favored THA, while instability remained an important concern.
A broader analysis of randomized trials reached a similar conclusion: neither procedure is the best answer for every patient.
Clinical guidelines provide useful selection principles, but they do not replace an assessment of the person who has been injured.
AK Medical's AK-Bipolar is one documented option for professional evaluation when bipolar hemiarthroplasty is being considered. The complete reconstruction must still be assessed for fixation, compatibility, clinical evidence and applicable regulatory authorization.
For families, the central question is not how much of the hip can be replaced.
It is which reconstruction gives this particular patient the most appropriate opportunity to recover safely and regain independence.
Contact AK Medical | Bipolar Hemiarthroplasty and Hip Reconstruction
AK Medical welcomes professional inquiries from orthopedic trauma surgeons, arthroplasty specialists, hospitals, procurement teams and international distributors.
Request AK-Bipolar Technical and Regulatory Documentation
International Sales Email: sales@ak-medical.net
AK Medical Acetabular and Bipolar Products:
https://www.ak-medical-global.com/products/acetabular-cup-system
International Product Catalogue:
https://www.ak-medical-global.com/products
Official Contact Page:
https://www.ak-medical.net/en/contact.html
Available documentation may include bipolar head specifications, compatible femoral components, instructions for use, surgical technique information, product-specific clinical evidence and applicable regulatory records.
Please include your country or region, institution, professional role and the documents required.
Product indications, configurations, availability and regulatory authorization vary by jurisdiction.
References
1. National Institute for Health and Care Excellence (NICE).
Hip Fracture: Management. Clinical Guideline CG124. Updated January 2023.
https://www.nice.org.uk/guidance/cg124/chapter/recommendations
2. American Academy of Orthopaedic Surgeons (AAOS).
Management of Hip Fractures in Older Adults. Evidence-Based Clinical Practice Guideline. 2021.
3. HEALTH Investigators.
Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture.
N Engl J Med. 2019;381(23):2199–2208.
DOI: 10.1056/NEJMoa1906190.
PMID: 31557429.
https://pubmed.ncbi.nlm.nih.gov/31557429/
4. Ekhtiari S, Gormley J, Axelrod DE, Devji T, Bhandari M, Guyatt GH.
Total Hip Arthroplasty Versus Hemiarthroplasty for Displaced Femoral Neck Fracture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
J Bone Joint Surg Am. 2020;102(18):1638–1645.
DOI: 10.2106/JBJS.20.00226.
PMID: 32732709.
https://pubmed.ncbi.nlm.nih.gov/32732709/
5. AK Medical.
AK-Bipolar — Official Product Catalogue.
https://www.ak-medical.net/upload/file/2026/05/08/220c37878ce298cbf900070f7f66d03d.pdf
6. Stryker.
UHR Universal Head Bipolar System — Manufacturer Surgical Documentation.
7. DePuy Orthopaedics / Johnson & Johnson MedTech.
Self-Centering Bi-Polar Head — Public Device Records.
https://accessgudid.nlm.nih.gov/devices/10603295003557
8. Tang X, Wang D, Liu Y, Chen J, Zhou Z, Li P, Ning N.
The comparison between total hip arthroplasty and hemiarthroplasty in patients with femoral neck fractures: a systematic review and meta-analysis based on 25 randomized controlled trials.
J Orthop Surg Res. 2020;15:596.
DOI: 10.1186/s13018-020-02122-6.
PMID: 33302984.
https://pubmed.ncbi.nlm.nih.gov/33302984/
Medical Information and Product Compliance Disclaimer
This article is intended for general medical education and professional information. It does not diagnose an individual patient or recommend a particular implant or procedure.
The patient scenario is illustrative and does not represent a verified AK Medical case.
The HEALTH trial and cited meta-analyses compare treatment strategies, not the clinical outcomes of AK-Bipolar, Stryker UHR or DePuy Self-Centering products. The HEALTH trial is included in the subsequent meta-analysis; the patient populations must not be counted as independent datasets.
Manufacturer information describes selected documented product characteristics. It does not establish clinical superiority, equivalence, reduced complications or commercial cost advantages.
The final surgical decision must reflect the patient's condition, fracture characteristics, current clinical guidance and the treating team's judgment.
Product indications, component compatibility, market availability and regulatory authorization must be verified for the exact implant model and destination country.
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