Sirius Hip Stem 34B and 38C (used in hip replacements)

Hazard alert - components mixed during manufacturing leading to increased risk of need for revision

11 December 2014

Consumers and health professionals are advised that Biomet Australia, in consultation with the TGA, has issued a hazard alert regarding two batches of the Sirius Hip Stem 34B and 38C.

Sirius Hip Stem 34B and 38C are components used in hip replacement surgery.

It has been identified that the 34B components and 38C components with batch numbers 024320 could have been mixed during manufacturing. Only a small number of patients were implanted with these devices in Australia.

If a patient was inadvertently implanted with the wrong component, it could result in adverse events and would increase the risk of the patient needing to undergo revision surgery.

Information for consumers

Biomet Australia has written to orthopaedic surgeons who have implanted Sirius Hip Stem 34B and 38C components, providing further information about the above issue.

Only a small number of patients have been implanted with these devices in Australia.

If you, or a person you care for, have had a hip replacement and have any questions or concerns about this issue, please contact your surgeon or the hospital where the surgery was undertaken.

Information for all health professionals

If you are treating a patient who has had a hip replacement, advise them that only a small number of patients have been implanted with these devices in Australia and the implanting surgeons have been contacted about this issue.

If your patient has been implanted with a Sirius Hip Stem and experiences any symptoms that might be associated with this issue, such as unexpected pain, leg length discrepancy or soft tissue tension, or if they continue to have questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.

Information for orthopaedic surgeons

Biomet Australia has written to orthopaedic surgeons who have implanted Sirius Hip Stem 34B and 38C components, providing further information about the above issue.

If you are treating a patient who has had a Sirius Hip Stem 34B or 38C component implanted, you are advised to monitor them for symptoms that might be associated with this issue, such as unexpected pain, leg length discrepancy or soft tissue tension.

If a 34B component is intended for implant but a 38C is implanted instead, a thin cement mantel could crack and cause adverse events that might lead to a revision. Additionally, the vertical and horizontal offsets may be larger than expected, which may cause the patient to have potential leg length discrepancy and improper soft tissue tension (too tight).

If a 38C component is intended for implant but a 34B is implanted instead, the vertical and horizontal offsets may be smaller than expected, which may cause the patient to have potential leg length discrepancy and improper soft tissue tension (too loose). Also, there would be a thicker cement mantel than expected.

If you have any questions or concerns about this issue, contact Biomet Australia on 02 9878 6100.

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.