BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM SHELL WITH MULTI HOLES

    MDR report key: 2871517 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02495
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 26, 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 WAS REVISED DUE TO SUBLUXATION. DURING THE REVISION SURGERY, A LARGE HEMATOMA WAS ENCOUNTERED. THE PREVIOUS TROCHANTER FRAGMENT WAS LOOSE AND A CABLE WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM SHELL WITH MULTI HOLES KWZ ZIMMER, INC. 61083710

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention #61056793 MANUFACTURED BY ZIMMER (B)(4)| CATALOG #00223200418, LOT #62133693| VERSYS FEMORAL HEAD: CATALOG #00801804005, LOT| CABLE-READY CERCLAGE CABLE WITH CRIMP:| TRILOGY LONGEVITY POLY LINER: CATALOG #00631007036| LOT #61216374 MANUFACTURED BY ZIMMER| IMPLANTED:| (B)(4)