BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT

Additional Manufacturer Narrative

BIOPOLY DID NOT RECEIVE THE EXPLANT FOR INSPECTION. THE SALES REPRESENTATIVE DID, HOWEVER, PROVIDE AN IMAGE OF THE EXPLANT. THE DEVICE APPEARED TO SHOW SIGNS OF ABRASIVE WEAR. THE REMAINING BIOPOLY MATERIAL WAS SECURELY ATTACHED TO THE TITANIUM STEM AND THE OSTEOSYNC MATERIAL WAS ALSO SECURELY ATTACHED. THE IMPLANT HAD BEEN SECURED IN THE BONE VIA PRESS FIT; HOWEVER, THERE WAS NO EVIDENCE THAT BONE CEMENT HAD BEEN USED. THE IMPLANT MANUFACTURING LOT MET ALL SPECIFICATIONS. ALTHOUGH IT CANNOT BE CONFIRMED, THE CAUSE APPEARS TO HAVE BEEN OVERSTUFFING OF THE JOINT ALONG WITH THE PHALANX BEING DEVOID OF CARTILAGE, A CONTRAINDICATION, LEADING TO EXCESSIVE AND ABRASIVE BIOPOLY WEAR, LEADING 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 THIS DEVICE. 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, IT WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.

Description of Event or Problem

BIOPOLY LEARNED FROM A SALES REPRESENTATIVE ABOUT A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT AFTER THE PATIENT PRESENTED OSTEOLYSIS/BONE RESORPTION.