BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 56/50 P

    MDR report key: 1060470 · Received June 13, 2008

    Report

    Report Number
    9613350-2008-00038
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD PAIN A YEAR AFTER SURGERY AND WAS TESTED FOR INFECTION AND METAL ALLERGIES. NO INFECTION IDENTIFIED BUT HIS METAL TESTING CAME BACK POSITIVE FOR COBALT, CHROMIUM, AND ALUMINUM. THE METAL CUP WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R