BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY W/ 20 LIP 32 GR2

    MDR report key: 1253023 · Received December 4, 2008

    Report

    Report Number
    1818910-2008-05745
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K861979
    Removal / Correction Number
    Z505/Z538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE IT'S RELEASE FOR DISTRIBUTION. ALTHOUGH UNAVAILABLE FOR EVALUATION, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER NEARLY 20 YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF POLY WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS POLY W/ 20 LIP 32 GR2 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 889470

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention