BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 5 15.0

    MDR report key: 2002702 · Received February 17, 2011

    Report

    Report Number
    1818910-2011-02545
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    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. PRODUCT INFO REQUIRED IN SEARCHING THE COMPLAINT DATABASE BY PRODUCT LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED PT PAIN. PROVIDED INFO SUGGESTED EXCESS SCAR TISSUE AND KNEE INSTABILITY WERE CONTRIBUTING FACTORS TO THE PT PAIN. ADD'L PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. BASED ON THE PERFORMED INVESTIGATION, 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 RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 5 15.0 NJL DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention