BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 12.5MM

    MDR report key: 1250774 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05582
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PMA074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. PROD INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED JOINT INSTABILITY. ALTHOUGH NO CONCLUSIONS COULD BE DRAWN, THE REPORTED PAIN IS LIKELY RELATED TO THE JOINT INSTABILITY. BASED ON THE INVESTIGATION FINDINGS, THEN NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD+ 12.5MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention