Tandem Bipolar Hip System

Hazard alert - potential need for revision surgery due to parts becoming detached

12 September 2016

Tandem Bipolar Hip System

Consumers and health professionals are advised that Smith & Nephew, in consultation with the TGA, is issuing a hazard alert for specific batches of the Tandem Bipolar Hip System. Smith & Nephew is also recalling unused stock of the devices.

Tandem Bipolar Hip System is an orthopaedic implant used in partial hip replacement procedures.

It has been identified that a number of devices from specific batches were manufactured with a retainer groove that is out-of-specification.

This could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery.

The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time.

If the third failure occurs, it could result in adverse events and require revision surgery.

The likelihood of implant detachment after surgery is very low. However, if it did occur, it would happen within the first few weeks after the operation and be clearly recognised by the patient (and confirmed by X-ray).

The affected product and batch numbers are:

Description Batch number
Tandem Intl Bipolar 41od 22id 13LM12870
Tandem Intl Bipolar 41od 22id 14AM02714
Tandem Intl Bipolar 44od 28id 13LM17160
Tandem Intl Bipolar 44od 28id 13MM04139A
Tandem Intl Bipolar 45od 28id 13KM24097
Tandem Intl Bipolar 45od 28id 13LM04114
Tandem Intl Bipolar 45od 28id 13MM04143
Tandem Intl Bipolar 45od 28id 14AM00474
Tandem Intl Bipolar 45od 28id 14AM00478
Tandem Intl Bipolar 45od 28id 14AM02716
Tandem Intl Bipolar 45od 28id 14AM02717
Tandem Intl Bipolar 48od 28id 13MM13695
Tandem Intl Bipolar 48OD 28ID 14AM16531
Tandem Intl Bipolar 48OD 28ID 14BM14336
Tandem Intl Bipolar 49OD 28ID 13MM10141
Tandem Intl Bipolar 49OD 28ID 13MM10159
Tandem Intl Bipolar 49OD 28ID 14BM15206
Tandem Intl Bipolar 50OD 28ID 14AM00603
Tandem Intl Bipolar 51OD 28ID 14BM15248
Tandem Intl Bipolar 52OD 28ID 13LM07425
Tandem Intl Bipolar 52OD 28ID 13MM13698
Tandem Intl Bipolar 52OD 28ID 14AM02687
Tandem Intl Bipolar 53OD 28ID 13LM04213
Tandem Intl Bipolar 53OD 28ID 14AM21697
Tandem Intl Bipolar 54OD 28ID 14BM11528
Tandem Intl Bipolar 55OD 28ID 13KM22761A
Tandem Intl Bipolar 55OD 28ID 13KM22762

Information for consumers

If you or someone you provide care for has received a Tandem Bipolar Hip System as part of a partial hip replacement, be aware of this issue.

Please note that the likelihood of part of your implant becoming detached after surgery is very low. If it did occur, it would happen within the first few weeks after the operation.

If you have any questions or concerns about this issue, talk to your health professional. If you experience unexpected pain, limited mobility or loss of range-of-motion in relation to your implant, contact the implanting orthopaedic surgeon.

Information for health professionals

Patients with an affected hip replacement system should be followed up by the implanting orthopaedic surgeon if possible, particularly if they complain of unexpected pain, limited mobility or loss of range-of-motion associated with their hip implant and/or surgery.

However, if you are treating a patient who has had a partial hip replacement and is concerned about this issue, but has no signs of potential disassociation of their implant or any other problem, reassure them that the likelihood of it occurring is very low.

Advise them that, if disassociation did occur, it would happen within the first few weeks after the operation.

Information for orthopaedic surgeons

Smith & Nephew has written to orthopaedic surgeons who have implanted Tandem Bipolar Hip System devices from the affected batches to provide further information about this issue.

If you are managing the treatment of a patient who has a Tandem Bipolar Hip System device from an affected batch, you are advised to maintain routine follow-up protocol for those patients.

Proactive revision is not recommended. Failure of the device will result in the patient experiencing pain, limited mobility or loss of range-of-motion.

Please note that the Tandem Bipolar Hip System Surgical Technique instructs the surgeon to listen for an audible ‘click’ when the components are locked to confirm proper assembly, so users should identify most issues associated with this recall action before implantation.

If you have any questions or concerns about this issue, contact Smith & Nephew on 02 9857 3918.

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.