BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS POLY W/ 10 LIP 32 GR4

    MDR report key: 1192012 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04335
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K861979
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER WEAR RELATED INCIDENTS AGAINST THE PROVIDED PROD AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. ALTHOUGH UNAVAILABLE FOR EVAL, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER NEARLY 20 YRS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD 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 PROD OR ADD'L INFO THAT CHANGES THIS CONCLUSION BE REC'D, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS POLY W/ 10 LIP 32 GR4 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA 172180

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention