Consumers and health professionals are advised that Stryker Orthopaedics, in consultation with the TGA, has issued a hazard alert for various sizes (36mm, 40mm and 44mm) of its LFITTM Anatomic CoCr V40TM Femoral Head due to the potential for femoral head/hip stem dissociation. All affected components were manufactured before 4 March 2011.
A femoral head is a component used in some hip replacement procedures.
Stryker has received a higher-than-expected number of complaints documenting femoral head/hip stem dissociation. The complaint rate is less than 0.3% for the products affected by the hazard alert.
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.
There is otherwise no need to change the follow-up advised by your surgeon.
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 health professionals
Stryker Orthopaedics 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 head/hip stem dissociation (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
Stryker Orthopaedics has written to orthopaedic surgeons who have implanted affected LFITTM Anatomic CoCr V40TM Femoral Head components advising them of this issue. The company advises that the following clinical conditions may potentially be related to femoral head/hip stem dissociation: dislocation, pain associated with implant loosening, peri-prosthetic fracture, revision to alleviate hazardous situation, leg length discrepancy, loss of mobility secondary to hip/stem trunnion fracture or femoral head/hip stem dissociation, pain requiring revision surgery, inflammatory response and adverse local tissue reaction, and noise during use.
Surgeons are advised to ensure patients are informed about the symptoms that could indicate femoral head/hip stem dissociation and the need to seek follow-up care if these symptoms arise.
The products affected by this hazard alert are:
| Catalog number | Head diameter | Offset |
|---|---|---|
| 6260-9-036 | 36mm | -5 |
| 6260-9-136 | 36mm | +0 |
| 6260-9-236 | 36mm | +5 |
| 6260-9-336 | 36mm | +10 |
| 6260-9-040 | 40mm | -4 |
| 6260-9-140 | 40mm | +0 |
| 6260-9-044 | 44mm | -4 |
| 6260-9-144 | 44mm | +0 |
If you have any questions or concerns relating to this issue, contact Stryker Australia on 1800 803 601.
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.