Description of Event or Problem · 0
ON [REDACTED] THE PATIENT UNDERWENT TEMPOROMANDIBULAR JOINT (TMJ) ARTHROPLASTY WITH A CUSTOM TOTAL JOINT REPLACEMENT (TJR) PROSTHESIS BY THE ORAL & MAXILLOFACIAL SURGERY SERVICE. AT THE TIME OF THE INDEX PROCEDURE ALL PATIENT-SPECIFIC CUTTING GUIDES AND PROSTHETIC COMPONENTS WERE VERIFIED PRE-OPERATIVELY AND NOTED TO FIT APPROPRIATELY INTRAOPERATIVELY. POSTOPERATIVELY, THE PATIENT WAS OBSERVED TO HAVE A RIGHT-SIDED POSTERIOR OPEN BITE (NOT THE PLANNED BITE FROM SURGERY). THE OCCLUSION WAS NOTED TO APPROXIMATE WITH GENTLE DIGITAL SUPERIOR REPOSITIONING OF THE MANDIBLE. THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. ON [REDATED] -27 DAYS AFTER SURGERY, THE SURGEON WAS CONTACTED BY REPRESENTATIVES OF TMJ CONCEPTS/STRYKER (THE ONLY FDA-APPROVED MANUFACTURER OF CUSTOM TJRS),AND INFORMED THAT THE RIGHT TMJ FOSSA COMPONENT IMPLANTED DURING THE INDEX PROCEDURE WAS NOT THE PATIENT-SPECIFIC COMPONENT FABRICATED FOR THE PATIENT, BUT RATHER A COMPONENT MANUFACTURED FOR ANOTHER PATIENT ON THE SAME PRODUCTION DATE, MEANING THAT THE INCORRECT PROSTHETIC COMPONENT WAS INSTALLED INTO THE PATIENT. THE REMAINING CUTTING GUIDES, MODELS, AND PROSTHETIC COMPONENTS WERE CONFIRMED TO CORRESPOND TO THE PATIENT. THE PROSTHESIS WAS CONTAINED IN A STERILIZATION BAG LABELED WITH THE PATIENT¿S DEMOGRAPHIC INFORMATION, SUGGESTING THAT THE ERROR LIKELY ORIGINATED AT THE MANUFACTURING FACILITY. THE PATIENT WAS NOTIFIED ON [REDACTED] -THE SAME DAY VIA A VIRTUAL VISIT WITH THE FAMILY. THE PLAN FOR THIS PATIENT IS TO UNDERGO REVISION SURGERY ONCE TMJ CONCEPTS/STRYKER MANUFACTURES AND SHIPS A NEW GLENOID PROSTHESIS - WHICH MAY TAKE ANYWHERE FROM 6-12 WEEKS. MANUFACTURER RESPONSE FOR TMJ CUSTOM BILATERAL IMPLANTS, CUSTOM IMPLANTS (PER SITE REPORTER). THE MANUFACTURER NOTIFIED US OF THE PROBLEM. THEY ARE MAKING ANOTHER IMPLANT.