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Patient 1
THE PATIENT RECEIVED ARTHROSURFACE TOEMOTION IMPLANTS BILATERALLY ON (B)(6) 2016 (LEFT SIDE) AND (B)(6) 2016 (RIGHT SIDE). ACCORDING TO THE SURGEON, THE RIGHT TOEMOTION PHALANGEAL IMPLANT LOOSENED OVER TIME AND LED TO PAIN IN THE PATIENT. HOWEVER, THERE ARE NO ISSUES WITH THE LEFT TOEMOTION IMPLANT. COPIES OF OPERATIVE NOTE AND POST-OP X-RAY WAS PROVIDED TO ARTHROSURFACE. THE EXACT REASON FOR THE LOOSENING IS UNKNOWN. AS A PART OF THE INVESTIGATION, INCOMING AND FINAL INSPECTION RECORDS (DHRS) OF THE LOTS IN QUESTION WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. ALL PARTS WERE BUILT TO SPECIFICATION AND NON-CONFORMING PARTS WERE APPROPRIATELY IDENTIFIED AND DISPOSITIONED ACCORDINGLY. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT STATES THAT THIS TYPE OF EVENT CAN OCCUR 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. 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 SAFETY FOR INTENDED PURPOSES. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. WE WILL CONTINUE TO MONITOR, TRACK AND TREND. THE PHALANGEAL COMPONENT WAS REMOVED UNEVENTFULLY AND AN INTERPOSITIONAL GRAFT WAS PLACED WHILE STILL RETAINING DF IMPLANT ON THE METATARSAL SIDE. FOLLOWING IS THE INFORMATION PERTAINING TO EXPLANTED DEVICES: PART # 9P15-S180; LOT: 75AF2810; MFG. DATE: 05/06/2016; EXP. DATE: 05/06/2021. PART # 9P15-PA01; LOT: 75AF0714; MFG. DATE: 02/17/2016; EXP. DATE: 02/17/2023.