BIOPOLY® GREAT TOE HIMIARTHROPLASTY IMPLANT

Additional Manufacturer Narrative

THE SURGEON INDICATED THAT THE IMPLANT WAS WELL FIXED. THE IMPLANT SHOWED SIGNS OF MACRO WEAR, INDICATING THAT IT WAS LIKELY ARTICULATING AGAINST A NON-CARTILAGE SURFACE. THE IFU WARNS THAT ARTICULATING THE IMPLANT AGAINST NON-CARTILAGE SURFACES CAN LEAD TO IMPLANT DAMAGE. FROM THIS INVESTIGATION, IT APPEARS THAT ARTICULATION AGAINST A NON-CARTILAGE SURFACE COULD HAVE LED TO MACRO WEAR OF THE IMPLANT.

Description of Event or Problem

BIOPOLY LEARNED FROM A SALES REP ABOUT A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT.