BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT

Additional Manufacturer Narrative

THE IMPLANT MANUFACTURING LOT MET ALL SPECIFICATIONS. BIOPOLY INTERVIEWED THE SURGEON, AND LEARNED THAT THE IMPLANT WAS USED IN A PATIENT WITH GRADE IV HALLUX RIGIDUS, AND THE IMPLANT WAS LIKELY ARTICULATING WITH A NON-CARTILAGE SURFACE. THIS IS WARNED AGAINST IN THE IFU, AS ARTICULATING WITH ROUGH SURFACES MAY LEAD TO EXCESSIVE AND ABRASIVE WEAR AND EVENTUALLY LEAD TO OSTEOLYSIS. 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). IF ADDITIONAL INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.

Description of Event or Problem

BIOPOLY LEARNED FROM A PHYSICIAN ABOUT A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT AFTER THE PATIENT PRESENTED WITH PAIN.