BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER GLENOSPHERE

    MDR report key: 2222889 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01819
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PROVIDED X-RAY DOES SHOW THAT THE GLENOSPHERE IS NOT EVENLY SEATED ON THE BASEPLATE. 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, INTERFACE WITH RETRACTORS, ETC. 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. HOWEVER AN EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINLY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE ITEM/LOT NUMBER WAS NOT AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE POST OPERATIVE X-RAYS SHOWED THAT THE GLENSPHERE WAS NOT SEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER GLENOSPHERE SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1