BI POLAR RADIAL CUP 19MM DIA

Description of Event or Problem

SUBJECT: (B)(6) ((B)(6) 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 (B)(6) 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTRUCTION USING HALF OF THE FLEXOR CARPI RADIALIS TENDON. THIS EVENT CORRESPONDS TO (B)(4) AND (B)(4). ON (B)(6) 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 RECORD CORRESPONDS TO THIS EVENT. ON (B)(6) 2022 : RE-OPERATION WITHOUT IMPLANT CHANGE : LIGAMENT RECONSTUCTION (BECAUSE OF PERSISTENCE OF THE POSTEROLATERAL RADIAL HEAD DISLOCATION) THIS EVENT WAS RESOLVED WITHOUT SEQUELAE AFTER LAST INTERVENTION. THIS EVENT CORRESPONDS TO (B)(4) AND (B)(4).

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.