AS INVERSE GLENOID FIXATION

Description of Event or Problem

IT IS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO PAIN AND IMPLANT LOOSENING (GLENOID COMPONENT). INITIAL SURGERY WAS ON (B)(6) 2006. THIS COMPLAINT IS RELATED TO THE ANATOMICAL SHOULDER INVERSE/REVERSE CLINICAL STUDY. NO RETRIEVALS ARE AVAILABLE FOR INVESTIGATION.

Additional Manufacturer Narrative

INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), CLINICALS DEPARTMENT, WHICH MARKETS THE DEVICES AND LEADS THE ABOVE MENTIONED CLINICAL STUDY IN (B)(4). THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).