HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

AT THE REQUEST OF ARTHROSURFACE, THE PATIENT PROVIDED X-RAYS AND PICTURES OF HIS RIGHT KNEE JOINT. LOOSENING, MISALIGNMENT OR OTHER MECHANICAL ISSUES WERE NOT EVIDENT FROM THE X-RAYS. HOWEVER, THE COLOR OF THE PATIENT'S SKIN APPEARED PALE RED FROM THE PICTURES PROVIDED. IT IS UNCLEAR IF THE COLOR CHANGE WAS DUE TO THE IMPLANT. ARTHROSURFACE HAS NO RECORD OR HISTORY OF PATIENTS WHO EXPERIENCED SKIN DISCOLORATION. AS A PART OF THE INVESTIGATION, THE SALES AND MANUFACTURING HISTORY OF THIS LOT WAS REVIEWED. NO COMPLAINTS CONCERNING STERILITY OR BIOCOMPATIBILITY ISSUES WERE REPORTED FOR THE HEMICAP® WAVE IMPLANTS TO DATE. AS SUCH, NO DISCREPANCIES WERE NOTED IN THE MANUFACTURING RECORDS OF THE LOTS IN QUESTION. ALL UNITS WERE BUILT TO SPECIFICATION. THE IMPLANT MATERIALS AND COMBINATIONS HAVE DECADES OF HISTORY FOR USE IN JOINT REPLACEMENT APPLICATIONS. ALSO, THE IMPLANT MATERIALS HAVE BEEN EVALUATED FOR BIOCOMPATIBILITY TO DEMONSTRATE SAFE AND INTENDED USE. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT LISTS ALL POSSIBLE ADVERSE EFFECTS AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC., CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. AN APPROPRIATE ROOT CAUSE FOR THE REPORTED ISSUES CANNOT BE ASCERTAINED WITH THE INFORMATION AVAILABLE. IT IS UNKNOWN IF THE PATIENT HAS SENSITIVITY TO COBALT-CHROME ALLOY AND TITANIUM DIOXIDE FOR WHICH THE PATIENT IS NOT YET BEEN TESTED TO. ARTHROSURFACE HAS REFERRED THE PATIENT TO ANOTHER PHYSICIAN FOR FURTHER TREATMENT. THE MDRS FOR OTHER PF WAVE DEVICES IN THE PATIENT ARE SUBMITTED SEPARATELY. CORRESPONDING REPORT NUMBERS ARE 3004154314-2019-00014 AND 3004154314-2019-00016.

Description of Event or Problem

THE PATIENT RECEIVED A HEMICAP® PATELLO-FEMORAL WAVE IMPLANT IN (B)(6) 2017 AND STARTED TO EXPERIENCE DEBILITATING PAIN, INFLAMMATION AND SKIN DISCOLORATION 60 DAYS FOLLOWING THE SURGERY. ON FOLLOWING-UP WITH THE SURGEON IN (B)(6) 2018 THE PATIENT WAS TESTED FOR INFECTION, CBC BLOODWORK, METAL ALLERGY (TITANIUM ALLOY ONLY) WHICH CAME BACK NEGATIVE. THE PATIENT IS UNSURE OF HIS SENSITIVITY TO CO-CR OR TITANIUM DIOXIDE AND HAS NOT TESTED FOR SENSITIVITY OF THOSE CHEMICALS TO DATE. ACCORDING TO THE IMPLANTING SURGEON, THE IMPLANT LOOKS PROPERLY ALIGNED AND TIGHT. THE PATIENT SUSPECTS IF HIS SITUATION COULD BE A CASE OF METALLOSIS.