BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR

    MDR report key: 1082725 · Received July 23, 2008

    Report

    Report Number
    1822565-2008-00435
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE POST MAY HAVE FRACTURED DUE TO HIGH, REPEATED IMPACTION FORCES. IN ORDER TO POTENTIALLY IMPROVE THE PERFORMANCE, THE MATERIAL HAS BEEN CHANGED TO ONE THAT IS LESS NOTCH SENSITIVE. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. AS RETURNED, THE ALIGNMENT PEG HAS FRACTURED OFF THE GLENOID IMPACTOR. THE FRACTURED PEG WAS NOT RETURNED WITH THE COMPLAINT FOR REVIEW. THE DEVICE MANUFACTURING RECORDS ARE INTACT AND CONFORMING, INDICATING THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE IN SURGERY, THE SURGEON WAS TRYING TO IMPACT THE IMPLANT AND THE METAL PRONG ON THE GLENOID IMPACTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR SHOULDER INSTRUMENT HSD ZIMMER, INC. NA 60915146

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK