BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG+ 10MM

    MDR report key: 1003554 · Received February 25, 2008

    Report

    Report Number
    1818910-2008-00718
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROX 4 YEARS AGO. EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INITIAL REPORTING INDICATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROVIDED INFO SUGGESTS THE PT ANATOMY (TISSUE) WAS A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED . DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS VERY LIMITED FLEXION WITH KNEE PAIN. SURGEON PERFORMED SOFT TISSUE RELEASES. MINOR POLY WEAR WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention