Australia’s TGA is cautioning healthcare providers that Zimmer’s Trabecular metal knee implant may contain non-sterile implant components that could result in post-operative infection.
Zimmer’s implants are packaged in a dual-barrier pouch containing an inner and outer pouch designed to provide sterile integrity. Testing conducted by Zimmer Biomet found tears in specific lots of foil packaging containing implant components in either inner or outer foil.
Potentially affected implants were distributed between April 2011 and March 2016. Clinicians are asked to inspect packaging and not use implants if any damage is visible. — Joya Patel