HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

THE SURGEON WAS ABLE TO FINISH THE CASE USING A PFXL TAPER POST COMPONENT READILY AVAILABLE WITH THE REP. AN ADDITIONAL TECHNIQUE STEP HAD TO BE PERFORMED TO USE THE TAPER POST AS AN ALTERNATIVE FIXATION COMPONENT. TWO GUIDE PINS WERE BROKEN WITH THEIR TIPS SEIZED IN PATIENT'S BONE WHILE PREPARING THE IMPLANT SITE. THERE IS NO CORRELATION BETWEEN THE FIXATION STUD IN QUESTION AND THE BROKEN PINS. HENCE, A SEPARATE MDR (REFERENCE MDR# 3004154314-2017-00018) WAS FILED TO REPORT THE BROKEN GUIDE PINS. THE SURGEON WAS HAPPY WITH THE FINAL OUTCOME OF THE CASE. THE FIXATION STUD IN QUESTION WAS RETURNED AND THE COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS, WE BELIEVE THAT THIS IS A 1-OFF INCIDENT THAT RESULTED DUE TO AN OPERATOR ERROR. THE OPERATOR IS NO LONGER WITH THE CONTRACT MANUFACTURING ORGANIZATION.

Description of Event or Problem

ARTHROSURFACE WAS NOTIFIED OF A FIXATION STUD THAT WOULD NOT MATE WITH ITS CORRESPONDING FEMORAL ARTICULAR COMPONENT. THE SURGEON SUSPECTS THAT THE STUD IN QUESTION MAY BE LACKING A TAPER FEATURE WHICH IS ESSENTIAL FOR MECHANICAL INTERLOCKING OF ARTICULAR AND FIXATION COMPONENTS.