BI POLAR RADIAL STEM 6.5 DIA

Description of Event or Problem

SUBJECT: (B)(6) (WELBOW CLINICAL STUDY) FEW DAYS AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, A DISLOCATION OF THE ELBOW (IN THE EVENT OF MAJOR INSTABILITY) WAS OBSERVED. IT WAS OBSERVED A AVULSION OF THE REATTACHMENT ANCHOR OF THE LATERAL LIGAMENTOUS PLAN RESULTED IN POSTERIOR DISLOCATION OF THE RADIAL HEAD. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE TO ADDRESS THIS ISSUE, THREE INTERVENTIONS WERE REQUIRED : ON 27 JUN 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING HALF OF THE FLEXOR CARPI RADIALIS TENDON. THIS EVENT CORRESPONDS TO 20243724469 AND 20243724470. ON 12 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING THE CONTROLATERAL PALMARIS LONGUS TENDON (BECAUSE OF RECURRENCE OF POSTEROLATERAL RADIAL DISLOCATION AFTER THE FIRST LIGAMENT). THIS EVENT CORRESPONDS TO 20243733255 AND 20243733256. ON 13 JUL 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION (BECAUSE OF PERSISTENCE OF THE POSTEROLATERAL RADIAL HEAD DISLOCATION) THIS EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER LAST INTERVENTION. THIS RECORD COVERS THIS EVENT ABOVE.

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.