HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

THE SURGEON NOTED THAT THE REASON FOR REVISION WAS PROGRESSION OF DISEASE, WHICH MAY HAVE CONTRIBUTED TO THE PAIN REPORTED BY THE PATIENT. SINCE THE IMPLANT DEVICE WAS NOT RETURNED FOR EVALUATION, WEAR REPORTED ON THE DEVICE (UHMWPE PATELLAR COMPONENT) COULD NOT BE CONFIRMED. DUE TO INADEQUATE INFORMATION IN THE SOURCE DOCUMENT RECEIVED, CONCLUSIONS CANNOT BE DRAWN ON THE CAUSE FOR REPORTED WEAR. AS NO PART NUMBER OR LOT NUMBER WERE PROVIDED, THE MANUFACTURING HISTORY OF THE IMPLANT DEVICE(S) REMOVED FROM THE PATIENT COULD NOT BE REVIEWED. ADDITIONAL INFORMATION PERTAINING TO DEVICES REMOVED FROM THE PATIENT WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

ARTHROSURFACE WAS NOTIFIED OF THE INFORMATION THAT A PATIENT IMPLANTED WITH ARTHROSURFACE HEMICAP PFXL DEVICE WAS REVISED DUE TO PAIN. THE SURGEON ALSO NOTED WEAR ON THE PATELLAR COMPONENT AT THE TIME OF THE REVISION SURGERY.