BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT

Description of Event or Problem

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

Additional Manufacturer Narrative

THE IMPLANT MANUFACTURING LOT MET ALL SPECIFICATIONS. BIOPOLY DID NOT RECEIVE THE EXPLANT FOR INSPECTION BUT DID RECEIVE AN IMAGE OF IT FROM THE DEVICE REP WHICH APPEARS TO SHOW POLYMER WEAR ON ONE SIDE. ALTHOUGH IT CANNOT BE CONFIRMED, THE CAUSE APPEARS TO HAVE BEEN OVERSTUFFING OF THE JOINT AND/OR THE PRESENCE OF EXPOSED BONE OR OSTEOPHYTES ON THE OPPOSING PHALANX SURFACE. IMPLANTING THE DEVICE AGAINST NON-CARTILAGE SURFACES IS WARNED AGAINST IN THE INSTRUCTIONS FOR USE. WEAR AND DAMAGE OF THE IMPLANT ARE POSSIBLE ADVERSE EFFECTS LISTED IN THE INSTRUCTIONS FOR USE (IFU) DOCUMENT AND CONSIDERED RISKS IN THE RISK MANAGEMENT SYSTEM FOR THE IMPLANT. MANY POSSIBLE FACTORS COULD LEAD TO DAMAGE TO THE IMPLANT DURING IMPLANTATION, INCLUDING FAILURE TO FOLLOW INSTRUCTIONS FOR USE, USE OF IMPLANT AGAINST NON-CARTILAGE SURFACE, OR IMPROPER PATIENT SELECTION (AGE, BONE QUALITY, CARTILAGE HEALTH). RETURN OF THE DEVICE WAS REQUESTED BUT IT HAS NOT BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, INCLUDING RETURN OF THE DEVICE, IT WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.