BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT-S IT ALLOCLASSIC SHELL, 52/II

    MDR report key: 2243798 · Received September 1, 2011

    Report

    Report Number
    9613350-2011-00582
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    June 11, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT YET RECEIVE THE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFO AND / OR THE DEVICE(S) INVESTIGATION RESULTS BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW WAS PUT IN TO FIX THE SHELL BUT IT WENT THROUGH THE SHELL HOLE. WHEN TAKEN OUT THE SCREW HOLE WAS DAMAGED, SO THE CUP HAD TO BE CHANGED. THE REVISION SURGERY WAS FOR CHANGING THE CUP DUE TO BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOFIT-S IT ALLOCLASSIC SHELL, 52/II ALLOFIT ACETABULAR SYSTEM KWB ZIMMER, INC. 2607949

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R