PROSTHESIS, TOE, HEMI-, PHALANGEAL

Additional Manufacturer Narrative

BASED ON THE REPORTED INFORMATION, IT IS UNKNOWN WHETHER THE IMPLANT WAS LOOSENED FROM THE BONE OR THE ARTICULAR COMPONENT WAS LOOSENED FROM THE TAPER POST. THE PATIENT DID NOT RESPOND TO FOLLOW-UP EMAILS FROM ARTHROSURFACE. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED AND NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. SINCE NO PART AND LOT INFORMATION WAS PROVIDED, REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) OF DEVICES IN QUESTION CANNOT BE CONDUCTED. 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, INFORMATION WILL BE REVIEWED, AND COMPLAINT FILE WILL BE AMENDED ACCORDINGLY.

Description of Event or Problem

PATIENT WITH AN UNKNOWN TOE IMPLANT BECAME LOOSE WITHIN 14 MONTHS OF SURGERY.