BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL GLENOSPHERE HELMET

    MDR report key: 1841988 · Received August 31, 2010

    Report

    Report Number
    1822565-2010-00634
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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. THE EXACT CAUSE ANALYSIS 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 REPEATED ATTEMPTS WERE MADE TO USE THE ENCLOSED GLENOSPHERE HELMET TO INSERT THE IMPLANT. THE PLASTIC FINGERS OF THE HELMET BROKE AND THE SURGEON WAS UNABLE TO SECURE THE IMPLANT FROM ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL GLENOSPHERE HELMET SHOULDER INSTRUMENT HSD ZIMMER, INC. 61237374

    Patients

    Seq Age Sex Outcome Treatment
    1