BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT

Description of Event or Problem

BIOPOLY LEARNED FROM PHYSICIAN ABOUT OSTEOLYSIS/BONE RESORPTION IN ONE OF HIS PATIENTS, AND THAT HE REMOVED THE BIOPOLY IMPLANT.

Additional Manufacturer Narrative

BIOPOLY RECEIVED THE EXPLANT FOR INSPECTION. THE EXPLANT WAS EXAMINED UNDER MAGNIFICATION AND 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 IS NOT CONFIRMABLE, 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 AND 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 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.