| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00493-1 |
| Product Name/Description |
BIRMINGHAM HIP Resurfacing (BHR) System
BHR Resurfacing Head
Catalogue Numbers: 74121138, 74123140, 74121142, 74123144, 74121146
BHR Acetabular Cup
Catalogue Numbers: 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152, 74120152, 74120154
BHR Dysplasia Cup
Catalogue Numbers: 74120246, 74122248, 74120250, 74122252, 74120254
ARTG numbers: 120078 & 124099 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew (S&N) has conducted an analysis of recent National Joint Registry of England and Wales data. The data indicate that the revision rates associated with the female gender, and smaller femoral head sizes regardless of gender, perform less well and exceed the current revision rate benchmark established by the UK National Institute for health and Care Excellence .
S&N is informing customers that:
- The use of BHR in female patients is to be contraindicated;
- BHR femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular cup sizes, are no longer to be used and are to be returned to S&N; and
- patients requiring a 48mm femoral head size are at a moderately elevated risk of revision and should not be considered as candidates for BHR implantation. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised that 48mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery. Surgeons are recommended to maintain their routine follow-up protocol for patients who have undergone hip resurfacing arthroplasty. Patients who experience symptoms including limited mobility, pain, swelling, enlarged bursae, pseudotumors, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has beem closed-out on 31/08/2016. |
| Contact Information |
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