BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL GLENOSPHERE HELMET

    MDR report key: 1831988 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00660
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DIMENSIONAL READINGS ARE CONFORMING TO PRINT SPECIFICATIONS. THIS TYPE OF FAILURE MAY OCCUR IF THE HELMET IS REMOVED FROM THE GLENOSPHERE IN A MANNER NOT CONSISTENT WITH THE METHOD DESCRIBED IN THE SURGICAL TECHNIQUE. ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. 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 PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HELMET TAB BROKE UPON GLENOSPHERE IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL GLENOSPHERE HELMET SHOULDER PROSTHESIS HSD ZIMMER, INC. 61145917

    Patients

    Seq Age Sex Outcome Treatment
    1