BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG+ 10MM

    MDR report key: 1398052 · Received May 29, 2009

    Report

    Report Number
    1818910-2009-02825
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    May 10, 2009
    Report Date
    May 10, 2009
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION IF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG+ 10MM 87NJL NJL DEPUY-RAYNHAM, A DIVISION IF DEPUY ORTHOPAEDICS, INC. NA CN8RB4000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention