| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00318-1 |
| Product Name/Description |
Birmingham Hip Modular Head (BHMH)
(component of MoM total hip replacement systems)
BHMH 38MM~62MM (Sleeved)
Catalogue Numbers: 74222138 to 74222162
12/14 Modular Taper Sleeve
Catalogue Numbers: 74222100, 74222200, 74222300, 74222400
All batches/lots
ARTG Number: 124100 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew (S&N) is issuing an update to the Oct 2012 Hazard Alert after analysis of new information identified that patients implanted with the BHMH may be at greater risk of revision surgery. The new revision risk estimate for the BHMH is:
-10.6% (95% CI: 9.55, 11.65) at six years follow-up from the National Joint Registry for England, Wales and Northern Ireland (data accessed in January 2015)..
- 11.7% (95% Cl: 9.7, 14.0) at ten years of follow-up from AOA NJRR (Report published in October 2014 based on data collected to end December 2013).
Also, a small clinical study undertaken in the UK with patients implanted with sleeved BHMH and uncemented SYNERGY stems indicates that there is a potential increased risk of fretting corrosion and accelerated release of metal debris at the taper junctions of the Modular Taper Sleeve interface with the stem and with the head. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
S&N recommends that physicians maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty. Patients may present with pain and limited mobility, potentially leading to a greater risk of revision surgery. Patients who experience symptoms including 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. For more information, please see http://www.tga.gov.au/alert/birmingham-hip-modular-head-used-hip-replacements This action has been closed-out on 31/08/2016. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical Pty Ltd |