HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

THE RADIOGRAPHS PROVIDED BY THE PATIENT WERE REVIEWED BY ARTHROSURFACE CEO AND HEAD OF ENGINEERING AND VP - CLINICAL AFFAIRS WHO CONCLUDED THAT THE TAPER POST COMPONENT IS PLACED TOO DEEP IN THE BONE WHICH RESULTED IN POOR FIXATION OF BOTH THE COMPONENTS. IT IS POSSIBLE THAT THE OPERATING SURGEON MAY NOT HAVE USED A TAPER DEPTH GAUGE FOR PLACEMENT OF THE SCREW. THE PATIENT IS CURRENTLY SEEKING OPINION ON FURTHER TREATMENT OPTIONS FOR WHICH ARTHROSURFACE HAS RESPONDED TO.

Description of Event or Problem

THE PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO REPORT PAIN IN HIS LEFT KNEE. HE RECEIVED A PFXL HEMICAP 1 YEAR AGO, AND SINCE HAS NOT RECEIVED PAIN RELIEF. FOLLOWING AN ARTHROSCOPY PROCEDURE RECENTLY, HIS SURGEON REMOVED SCAR/ INFLAMMATORY TISSUE IN THE KNEE WHICH REDUCED INFLAMMATION BUT NOT PAIN. THIS INFORMATION WAS FORWARDED TO ARTHROSURFACE VP - CLINICAL AFFAIRS, FOR REVIEW. THE PATIENT WAS ADVISED TO CONSULT HIS TREATING SURGEON OR TO OBTAIN A SECOND OPINION REGARDING HIS ON-GOING ISSUES. THE PATIENT OBTAINED SECOND OPINION FROM 2 OTHER DOCTORS AND WAS TOLD THAT HIS HEMICAP IS LOOSE.