| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01167-1 |
| Product Name/Description |
Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)
Material Numbers: 71324041, 71324044, 71324045, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055,
Multiple Batch Numbers affected
ARTG Number: 242993 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew have identified a manufacturing error which affects certain batches. The affected devices were manufactured with a retainer groove that is out-of-specification. The out of specification condition could potentially result in one of three functional failures: the device will not assemble, the head is too tight or in rare occasions, the device may appear to be assembled properly during surgery but later disassociate post-operatively. 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). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Smith & Nephew is advising users that there is no recommendation for proactive revisions. Failure of the device will result in the patient experiencing pain, limited mobility or loss of range-of-motion. Surgeons should maintain their routine follow-up protocol for patients who have been implanted with a potentially affected device.
Smith & Nephew is advising users to inspect stock and quarantine the affected devices for return. Affected devices can be returned for credit or replaced with unaffected product. This action has been closed-out on 24/05/2017. |
| Contact Information |
02 9857 3918 - Smith & Nephew |