BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT

Additional Manufacturer Narrative

THE IMPLANT MANUFACTURING LOTS MET ALL SPECIFICATIONS. BIOPOLY DID NOT RECEIVE THE EXPLANT FOR INSPECTION BUT DID RECEIVE AN IMAGE OF THE IMPLANT FROM IMMEDIATELY BEFORE EXTRACTION THAT APPEARS TO SHOW POLYMER WEAR. ALTHOUGH IT CANNOT BE CONFIRMED, THIS FAILURE IS LIKELY DUE TO EXPOSED BONE ON PHALANGEAL SURFACE, OSTEOPHYTES OR A ROUGHENED BONEY EDGE ON PROXIMAL PHALANX, OR A TIGHT JOINT. 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.

Description of Event or Problem

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