BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LINER

    MDR report key: 2820089 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-27474
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    August 7, 2001
    Report Date
    October 26, 2012
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REJECTION. AFTER FURTHER REVIEW OF THE COMPLAINT PRODUCT WAS FOUND TO BE NON-DEPUY PRODUCT.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED FOR OSTEOLYSIS AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LINER LINER JDI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention