BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM SHELL WITH MULTI HOLES

    MDR report key: 2871503 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02494
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM SHELL WITH MULTI HOLES KWZ ZIMMER, INC. 61073710

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention LOT #61216374 MANUFACTURED BY ZIMMER| (B)(4)| LOT #61056793 MANUFACTURED BY ZIMMER| TRILOGY LONGEVITY POLY LINER: CAT # 00631007036,| IMPLANTED:| VERSYS FEMORAL HEAD: CAT #00801804005,| IMPLANTED:| (B)(4)