HEMICAP - PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

AS SOON AS THE COMPLAINT WAS RECEIVED, IT WAS FORWARDED TO THE EUROPEAN DISTRIBUTOR TO FOLLOW-UP WITH THE PATIENT. THE DISTRIBUTOR DID NOT RECEIVE ANY RESPONSE FROM THE PATIENT AFTER ADVISING TO CONSULT THE DOCTOR REGARDING HER ISSUES. ARTHROSURFACE IS REGULARLY FOLLOWING-UP WITH THE DISTRIBUTOR FOR NEW INFORMATION REGARDING ISSUES FROM THE PATIENT OR THE TREATING PHYSICIAN. THE MANUFACTURING RECORDS (PACKAGE AND THE COMPONENT LEVELS) OF THE METAL AND UHMWPE COMPONENTS WERE REVIEWED. ALL PARTS MANUFACTURED, INSPECTED AND PACKAGED PER SPECIFICATIONS. THERE ARE NO ISSUES RELATIVE TO THE PATIENT'S COMPLAINT. THE SURGICAL HISTORY OF COMPONENT LOTS IN QUESTION (HEMICAP AND THE UHMWPE PATELLA) WAS REVIEWED AND NO COMPLAINTS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT. THE REASONS FOR THE PAIN CANNOT BE CONCLUDED WITH THE INFORMATION AVAILABLE AT THIS TIME. HOWEVER, VARIOUS ASPECTS SUCH AS PATIENT FACTORS, SURGICAL/ OPERATING TECHNIQUE, COMPLIANCE TO POST-OPERATIVE REHABILITATION TECHNIQUE ETC CONTRIBUTE TO THE OUTCOME OF THE SURGERY AND FUNCTIONALITY OF THE IMPLANTS. THE PATELLA COMPONENT IN QUESTION WAS NOT RETURNED AND HENCE THE DEVICE EVALUATION COULD NOT BE PERFORMED. SHOULD ARTHROSURFACE RECEIVE ANY NEW OR ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY.

Description of Event or Problem

THE COMPLAINANT IS A EUROPEAN PATIENT WHO REACHED OUT TO ARTHROSURFACE VIA WEBSITE. THE PATIENT RECEIVED ARTHROSURFACE PATELLO-FEMORAL XL RESURFACING IMPLANTS IN (B)(6) 2015 AND DID NOT GET PAIN RELIEF AS EXPECTED. SHE STATES THAT HER UHMWPE PATELLA CAP WAS WORN OUT WITHIN 18 MONTHS OF IMPLANTATION AND WAS INFORMED THAT THE DEVICE'S LIFE EXPECTANCY IS AT LEAST 15 YEARS. SHE IS CONCERNED THE IMPLANT MATERIAL IS A MISTAKE.