BI POLAR RADIAL CUP 19MM DIA

Description of Event or Problem

AS REPORTED: "DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) PROSTHESIS PLACEMENT ON (B)(6) 2022, SUBLUXATION NOTED ON THE VISIT OF (B)(6) 2022, PROSTHESIS CHANGE ON (B)(6) 2022. TO ADDRESS THIS MATTER COMPREHENSIVELY, A CORRECTIVE RE-OPERATION WAS CONDUCTED. THIS INVOLVED THE EXTRACTION OF THE EXISTING IMPLANT AND THE SUBSEQUENT RE-IMPLANTATION OF A NEW PROSTHESIS."

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.