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Consumers and health professionals are advised that Surgical Specialities, in consultation with the TGA, has issued a hazard alert for one model of its Profemur cobalt-chrome femoral neck (part number PHAC1254 – 'long 8-degree varus') due to the potential for the component to fracture.
Surgical Specialities is also undertaking a recall of unimplanted stock.
The Profemur cobalt-chrome femoral neck is a component used in some hip replacement procedures.
Component fractures are extremely rare, however the manufacturer reported there had been 27 reports of fracture of the PHAC1254 component in approximately 9800 units sold worldwide over the previous five years.
Only 32 units have been sold in Australia.
No other components in the Profemur cobalt-chrome femoral neck range have been identified as being affected by this issue.
A Profemur cobalt-chrome
femoral neck with the
potential fracture area
highlighted.
The TGA has received no reports of Profemur cobalt-chrome femoral necks fracturing in Australia.
Information for consumers
Patients who have had a hip replacement should seek immediate medical attention if they experience symptoms such as the sudden onset of:
- pain
- instability
- difficulty walking or performing common tasks.
If you have concerns about your hip replacement, you should seek information from the surgeon who performed the operation or the hospital where the operation was performed.
Information for all health professionals
Surgical Specialities has written to orthopaedic surgeons who have implanted affected components providing further information.
If you are treating patients who have had a hip replacement and are concerned about the above issue, advise them to be alert to the potential symptoms of a femoral 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 an implant was not functioning correctly and seek medical attention.
If patients continue to have questions or concerns, refer them to their surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
The sponsor Surgical Specialities has written to orthopaedic surgeons who have implanted affected PHAC1254 components advising them of this issue.
The sponsor has advised that the length of the affected component means that it experiences higher bending force than others in the Profemur cobalt-chrome femoral neck range and represents the model with the lowest mechanical strength under clinical conditions. No other components in the Profemur cobalt-chrome femoral neck range have been identified as being affected by this issue.
The sponsor has advised that it would not be possible to identify potentially affected components through visual inspection or during surgery.
Surgeons are advised to ensure patients are informed about the symptoms that could indicate component fracture and the need to seek follow-up care if these symptoms arise.
If you have any questions or concerns relating to this issue, contact Surgical Specialities by phone on 1300 665 884.
Reporting problems
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.