BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM REVERSE SHOULDER POLY LINER

    MDR report key: 2891465 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02502
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOS OF THE LINER WERE NOT PROVIDED. AS SUCH, A DETERMINATION REGARDING THE CONDITION OF THE LINER CANNOT BE MADE AT THIS TIME. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: 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 STEM SUBSIDED WHEN IMPACTING THE LINER. THE SURGEON WAS HAVING DIFFICULTY IMPACTING THE LINER ONTO THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TM REVERSE SHOULDER POLY LINER HSD ZIMMER, INC. 62096358

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR