BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 10MM

    MDR report key: 2032402 · Received March 28, 2011

    Report

    Report Number
    1818910-2011-05202
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S116
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ADD'L REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN AND SWELLING BASED ON THE PROVIDED INFO. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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 ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAINFUL AND SWOLLEN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG 10MM NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA EV5LM4

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention