AS INVERSE GLENOID FIXATION

Additional Manufacturer Narrative

THE MFR DID NOT RECEIVE 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. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PT RECEIVED AN INVERSE GLENOID FIXATION ON (B)(6) 2008 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2009 DUE TO LOOSENING OF THE GLENOID BASE PLATE. THE COMPLICATION WAS REPORTED BY THE STUDY SITE AS NOT BEING RELATED TO THE DEVICE.