BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE SHOULDER GLENOSPHERE HELMET

    MDR report key: 2150559 · Received June 22, 2011

    Report

    Report Number
    1822565-2011-01480
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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. HOWEVER, THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. AS RETURNED THE TM REVERSE HELMET HAS A FRACTURED TAB. THE HELMET HAS AN APPROXIMATE FIELD AGE OF 2 YEARS. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLENOSPHERE HELMET TAB IS BROKEN. IT IS UNK WHEN THE FRACTURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM REVERSE SHOULDER GLENOSPHERE HELMET LXH ZIMMER, INC. 61207698

    Patients

    Seq Age Sex Outcome Treatment
    1