BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML/TL HYL REP LINER 32X50SP

    MDR report key: 2592334 · Received May 30, 2012

    Report

    Report Number
    1818910-2012-08595
    Event Type
    Injury
    Date Received
    May 30, 2012
    Report Date
    March 11, 2010
    Manufacturer
    DEPUY WARSAW
    Product Code
    JDI
    PMA / PMN Number
    K942966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. THE INVESTIGATION HAS ALSO DETERMINED THAT THIS PRODUCT CODE IS NOW OBSOLETE. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED BECAUSE OF POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML/TL HYL REP LINER 32X50SP HIP LINER JDI DEPUY WARSAW 375420002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention