AS INVERSE HUMERAL CUP, OFF CENTER +9

Description of Event or Problem

THE FOLLOWING WAS REPORTED: PT IS A SUBSTANCE ABUSER AND HAS NEVER COMPLIED TO DR'S ADVICE REGARDING BRACES, ETC. SHOULDER HAD DISLOCATED MANY TIMES. SURGEON THUS DECIDED TO CONVERT INVERSE / REVERSE SHOULDER TO AN ANATOMIC HEMI SHOULDER. MOREOVER IT WAS REPORTED THAT THE SURGEON ONLY REMOVED GLENOID COMPONENTS TO ACCOMMODATE HER PT'S REQUEST. SHE WAS PLEASES WITH INITIAL FIXATION AND STABILITY.

Additional Manufacturer Narrative

THE MANUFACTURER DID NOT YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR 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 INFORMATION PROVIDED. HOWEVER THERE IS NO INDICATION FOR A PRODUCT FAILURE. 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 CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).