BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN MB INSERT SZ3 9.5MM

    MDR report key: 2151331 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11790
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P910016/S012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF PRODUCT TO EXAMINE. 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 THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING AND SUBSIDENCE OF THE TIBIAL TRAY. THE LOOSENING OCCURRED AT BOTH INTERFACES. THE MFR OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNK. POLY WEAR OF THE TIBIAL INSERT WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN MB INSERT SZ3 9.5MM 87NJL NJL DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS NA 1921107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention