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Profemur hip replacement components
Hazard alert - titanium modular necks pose small risk of fracture
Consumers and health professionals are advised that MicroPort Orthopedics, in consultation with the TGA, has initiated a hazard alert for all lot numbers of Profemur Long and Extra-Long Titanium Modular Necks due to the risk of the implant fracturing.
Profemur Titanium Modular Necks are a component used in some hip replacement procedures.
A component with the potential to fracture cannot be detected during surgery or by visual inspection or any other diagnostic technique. While fractures are rare, should one occur the patient may experience sudden pain, instability and difficulty walking/performing common tasks.
The total global fracture rate of Long and Extra-Long Profemur Titanium Modular Necks is currently 0.552 per cent. The fracture rate in Australia is currently 0.997 per cent with six fractures reported in Australia from 2002 to 2019.
Profemur Titanium Long and Extra-Long Modular Necks have not been used in Australia since 2012 and were cancelled from the Australian Register of Therapeutic Goods in 2015.
No other MicroPort Orthopedics Inc. products are included in this hazard alert.
Information for consumers
If you, or someone you provide care for, had a hip replacement in 2012 or earlier there is the potential that an affected Profemur component may have been used.
Due to the sudden pain and loss of mobility, it is expected the patient will recognise immediately if a component fractures and seek medical attention.
A fractured femoral neck will require surgery to correct. Surgeons have been advised only to undertake this surgery if the component has fractured, not in otherwise unaffected patients.
People who have had hip replacements are advised to discuss the issue with their surgeon during follow-up consultations, or with another health professional.
Information for health professionals
The fractured components occur when stresses produced at the modular neck/stem taper interface in heavy and/or highly active patients in whom predominantly longer offsets can exceed the fatigue strength of the modular neck.
If you are treating a patient who has had a hip replacement, alert them to this issue and advise them to discuss it with their orthopaedic surgeon at the next consultation.
Information for orthopaedic surgeons
MicroPort Orthopedics has written to all surgeons who have received supplies of the affected components to advise them of the hazard alert.
Surgeons are advised that MicroPort Orthopedics does not recommend prophylactic revision surgery, but does advise continuing to monitor the relevant patients according to the standard follow-up protocol.
If you are treating patients who have had hip replacements and are concerned about the issue, advise them to be alert to the potential symptoms of a modular neck component fracture (the sudden onset of symptoms such as pain, instability and difficulty walking or performing common tasks). It is likely that patients would immediately identify that there is a problem and seek medical attention.
The affected lots are:
- PHA01204 Profemur neck NEUTRAL - LONG
- PHA01214 Profemur neck A/R VAR/VAL 2 - LONG
- PHA01224 Profemur neck A/R VAR/VAL 1 - LONG
- PHA01234 Profemur neck 8DG A/R - LONG
- PHA01244 Profemur neck 15DG A/R - LONG
- PHA01254 Profemur neck 8DG VAR/VAL - LONG
- PHA01264 Profemur neck 15DG VAR/VAL - LONG
- PHA01206 Profemur neck NEUTRAL - EXTRA LONG
- PHA01236 Profemur neck 8DG A/R - EXTRA LONG
- PHA01256 Profemur neck 8DG VAR/VAL - EXTRA LONG
For further information call MicroPort Orthopedics on 1300 665 884 or email PostMarket@ortho.microport.com.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.