BI POLAR RADIAL STEM 8MM DIA

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

SUBJECT: (B)(6) WELBOW CLINICAL STUDY. ONE DAY AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, A CHANGE IN THE DIMENSIONS OF THE OPERATED LIMB WAS OBSERVED. IT WAS DETERMINED THAT A SHORT RADIAL BONE CUT HAD CAUSED AN ELBOW DISLOCATION. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT PROLONGATION OF EXISTING HOSPITALIZATION BY 3 DAYS TO ADDRESS THIS ISSUE, REVISION SURGERY WAS REQUIRED (RE-OPERATION WITH IMPLANT CHANGE) ON (B)(6) 2024.