Database updated: 20 December 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18345 |
| Brand Name: | S&N Birmingham Hip Modular Head, 36mm to 62mm |
| Model: | Catalogue Numbers: 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Orthopaedics Ltd |
| Issue: | In October 2012, Smith & Nephew issued a Hazard Alert informing surgeons and hospitals that the BIRMINGHAM HIP™ Modular Head had been identified in the Australian National Joint Replacement Registry (NJRR) and the National Joint Registry of England and Wales (NJREW) as having a higher than expected revision rate when compared to all other total conventional hip replacements. In late 2014, Smith & Nephew became aware of new information relating to the performance of BHMH. Also, recent registry and clinical data has showed a decline in the performance of the BHMH. Based on the analysis of this information, Smith & Nephew considers that patients implanted with the BHMH device may be at greater risk of revision surgery. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 16/4/2015 |
