News
Birmingham Hip Resurfacing system. Update - recall and new hazard alert
The TGA published information on 6 February 2015 based on a previous hazard alert issued for this device.
Since then, based on further consideration of the data, Smith & Nephew has taken the following strengthened actions:
- The BHR system is no longer to be used for female patients.
- BHR femoral head components sized 46 mm in diameter and smaller, and their corresponding acetabular cup sizes, are being withdrawn from the market and unused stock should be returned to Smith & Nephew.
- Patients requiring a 48 mm femoral head size should not be considered as candidates for BHR implantation due to a moderately elevated risk of revision. The 48 mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50 mm to a measured 48 mm at the time of surgery.
Read more here.
Last modified: Thu, 02 Jul 2015 14:43:27 BST