BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 28MM +0 M HEAD

    MDR report key: 1051137 · Received May 21, 2008

    Report

    Report Number
    1818910-2008-01881
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PROD AND/OR LOT CODES WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISLOCATION. POLY WEAR WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM 28MM +0 M HEAD 87JDI JDI DEPUY INTL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention