BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE SHOULDER GLENOSPHERE HELMET

    MDR report key: 2081979 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00845
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, ONE OF THE TABS OF THE GLENOSPHERE HELMET HAS FRACTURED AND IS MISSING. THE DEVICE HAS AN APPROXIMATE FIELD AGE OF 9 MONTHS AND HAS BEEN USED AN UNK NUMBER OF TIMES. 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. THE INSTRUMENT IS DESIGNED TO HOLD THE GLENOSPHERE SECURELY VIA THE TABS. EXCESSIVE IMPACT OR BENDING LOADS PLACED ON THE TABS MAY CAUSE THIS SITUATION. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINLY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPEC. DIMENSIONAL ANALYSIS FOUND THE PART WITHIN SPEC WHERE MEASURED. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HELMET CRACKED DURING GLENOSPHERE IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM REVERSE SHOULDER GLENOSPHERE HELMET LXH ZIMMER, INC. 61487660

    Patients

    Seq Age Sex Outcome Treatment
    1