BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE STEM

    MDR report key: 2841954 · Received November 14, 2012

    Report

    Report Number
    1822565-2012-02326
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IS IT REPORTED THAT DURING THE IMPACTION OF THE POLY, THE STEM SUBSIDED AND THE PROXIMAL HUMERUS FRACTURED AT THE RESECTION LINE. THE HUMERUS WAS THEN WIRED WITH CERCLAGE CABLE AND THEN OVERREAMED SO THE STEM COULD BE IMPLANTED. A NEW LINER WAS IMPACTED ONCE CEMENT WAS CURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL REVERSE STEM HSD ZIMMER, INC. 62078555

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other