BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY NPS INSERT

    MDR report key: 1595220 · Received February 2, 2010

    Report

    Report Number
    1818910-2010-00351
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 6, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED FOR EXAM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCTS TO EXAMINE. PROVIDED INFO STATED DEVICE LOOSENING AND POLYETHYLENE WEAR WERE THE ROOT CAUSE OF THE JOINT INSTABILITY. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INSTABILITY CAUSED BY FEMORAL LOOSENING AND POLY WEAR OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY NPS INSERT TOTAL KNEE PROSTHESIS HSH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention