UNK

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT REPORTED VIA EMAIL THAT THEY PREVIOUSLY UNDERWENT SURGERY ON THEIR RIGHT ANKLE IN WHICH ARTHREX IMPLANTS WERE UTILIZED. THE PATIENT STATED THAT THEY HAVE EXPERIENCED PERSISTENT ANKLE PAIN FOR APPROXIMATELY SIX MONTHS AND ARE CURRENTLY UNABLE TO WALK PROPERLY. NO ADDITIONAL CLINICAL DETAILS OR PROCEDURAL INFORMATION WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-FEB-2026: ON (B)(6) 2025, THE PATIENT UNDERWENT AN AITFL/PTFL STABILIZATION PROCEDURE (AITFL SYNDESMOSIS AND PTFL ARTHREX BRACE) FOR TREATMENT OF AN ANTERIOR INFERIOR TIBIOFIBULAR LIGAMENT TEAR AND POSTERIOR TIBIOFIBULAR LIGAMENT TEAR. THE PATIENT REPORTED THE ONSET OF POSTOPERATIVE PAIN ON THE DAY OF SURGERY, WHICH HAS CONTINUED TO THE PRESENT. THE PATIENT STATED THEY CONTINUE TO USE CRUTCHES SIX MONTHS POSTOPERATIVELY AND ARE PARTICIPATING IN PHYSICAL THERAPY. THE PATIENT REPORTED ONGOING PAIN AND NUMBNESS BUT NOTED NO ANKLE INSTABILITY. THE PATIENT STATED THEY WERE INFORMED THAT THE IMPLANTED DEVICES MAY BE IRRITATING NEARBY NERVES AND THAT IMPLANT REMOVAL MAY BE NECESSARY. NO ADDITIONAL CLINICAL OR PROCEDURAL DETAILS WERE PROVIDED.