BIRMINGHAM HIP RESURFACING SYSTEM (2015-06-04)

Starting date:

June 4, 2015

Posting date:

June 26, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Identification number:

RA-53952

• 
  Reason
• 
  Affected products

Recalled Product

A.BIRMINGHAM HIP RESURFACING SYSTEM (BHR) -  ACETABULAR CUPS

B.BIRMINGHAM HIP RESURFACING SYSTEM (BHR) -  DYSPLASIA CUPS

C.BIRMINGHAM HIP RESURFACING SYSTEM (BHR) -  FEMORAL HEADS

Reason

As part of its post market surveillance (PMS) and post-marketing clinical follow-up processes, Smith & Nephew has conducted an analysis of recent National Joint Registry of England and Wales (NJREW) data, (the largest arthroplasty registry cohort of BHR patients). A health hazard evaluation (HHE) was conducted to review this analysis. The data indicate that the BHR System continues to perform well in the male population requiring femoral head components 50mm in diameter and larger. However, 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 (NICE).

Affected products