BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML PLUS 62MM GR3

    MDR report key: 1034012 · Received April 25, 2008

    Report

    Report Number
    1818910-2008-01339
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K861979
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES CONFIRMS POLY MATERIAL WEAR. IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 18 YEARS OF IMPLANTATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED ACETABULAR CUP PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION IN 1989. 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. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS OSTEOLYSIS, POLYETHYLENE WEAR, AND LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML PLUS 62MM GR3 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 943280

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention