BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE

    MDR report key: 1001920 · Received February 21, 2008

    Report

    Report Number
    1822565-2008-00063
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE GLENOSPHERE NOT SEATING PROPERLY ONTO THE BASE PLATE MAY BE CAUSED BY SOFT TISSUE OR BONE TRAPPED AROUND THE BASE PLATE TAPER DURING GLENOSPHERE INSERTION, INSUFFICIENT BONE CLEARANCE AROUND THE BASE PLATE, INTERFERENCE WITH RETRACTORS, ETC. EACH SCENARIO COULD POTENTIALLY CAUSE THE GLENOSPHERE TO NOT COMPLETELY SEAT ON THE BASE PLATE. STRAIGHT-ON EXPOSURE OF THE GLENOID IS NECESSARY FOR BOTH PROPER REAMING AND COMPONENT INSERTION. THE USE OF BASE PLATE REAMER 2 (36MM) IS NEEDED TO REMOVE BONE AROUND THE BASE PLATE TO AVOID IMPINGEMENT WITH THE GLENOSPHERE. PER THE INFO PROVIDED, THE SURGEON SUSPECTED THAT THE GLENOSPHERE MAY HAVE NOT BEEN PROPERLY ASSEMBLED TO THE BASE PLATE COMPONENT AT THE TIME OF THE INITIAL SURGERY. NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. THE DEVICE WAS REVISED TWENTY-THREE DAYS LATER, DUE TO THE GLENOSPHERE DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE SHOULDER PROSTHESIS HSD ZIMMER, INC. NA 60752933

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R