BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2823074 · Received October 29, 2012

    Report

    Report Number
    MW5027503
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    April 2, 2012
    Report Date
    October 29, 2012
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEPUY SIGMA KNEE FAILURE BECAUSE OF CHROMIUM AND COBALT. REF NUMBER - (B)(4), LOT - 2907259; (B)(4), LOT NUMBER - 2890009; (B)(4), LOT - 2891006; (B)(4), LOT - 2892484.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SIGMA RP KNEE JWH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization THERAPY STARTED ON (B)(6) 2012.