BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEM RESTRICTOR LG

    MDR report key: 1692248 · Received May 14, 2010

    Report

    Report Number
    1818910-2010-02862
    Event Type
    Injury
    Date Received
    May 14, 2010
    Date of Event
    April 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDK
    PMA / PMN Number
    K800894
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE REPORTED PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT HAD STAPH INFECTION 2-3 MONTHS POST-OP WHICH DID NOT RESPOND TO CONSERVATIVE TREATMENT. THEREFORE, THE PT WAS REVISED AND A CEMENT SPACER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEM RESTRICTOR LG 87JDS JDK DEPUY ORTHOPAEDICS, INC. NA DX9KT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention