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

AS REPORTED:" SUBJECT: (B)(6) (WELBOW CLINICAL STUDY). 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 DISLOCATION OF THE LEFT ELBOW ACCOMPANIED BY A CRACKING SENSATION DURING FLEXION AND EXTENSION MOVEMENTS . ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE IMPLANT BUT POSSIBLY RELATED TO THE SURGERY THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿PROLONGATION OF EXISTING HOSPITALIZATION BY 14 DAYS . TO ADDRESS THIS ISSUE, REVISION SURGERY WAS REQUIRED (RE-OPERATION WITH IMPLANT CHANGE) ON (B)(6) 2022."

Additional Manufacturer Narrative

PLEASE NOTE CORRECTION TO IMDRF INVESTIGATION CODES (METHOD, RESULTS, AND CONCLUSION). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

AS REPORTED:" SUBJECT: (B)(6) (WELBOW CLINICAL STUDY). 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 DISLOCATION OF THE LEFT ELBOW ACCOMPANIED BY A CRACKING SENSATION DURING FLEXION AND EXTENSION MOVEMENTS . ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE IMPLANT BUT POSSIBLY RELATED TO THE SURGERY. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿PROLONGATION OF EXISTING HOSPITALIZATION BY 14 DAYS. TO ADDRESS THIS ISSUE, REVISION SURGERY WAS REQUIRED (RE-OPERATION WITH IMPLANT CHANGE) ON (B)(6) 2022."

Description of Event or Problem

AS REPORTED:" SUBJECT: (B)(6) (WELBOW CLINICAL STUDY). 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 DISLOCATION OF THE LEFT ELBOW ACCOMPANIED BY A CRACKING SENSATION DURING FLEXION AND EXTENSION MOVEMENTS. ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE IMPLANT BUT POSSIBLY RELATED TO THE SURGERY. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT ¿PROLONGATION OF EXISTING HOSPITALIZATION BY 14 DAYS. TO ADDRESS THIS ISSUE, REVISION SURGERY WAS REQUIRED (RE-OPERATION WITH IMPLANT CHANGE) ON (B)(6) 2022."

Additional Manufacturer Narrative

PLEASE NOTE CORRECTION TO D4 (LOT/SERIAL NO.). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.