BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 40 -2

    MDR report key: 3514418 · Received December 11, 2013

    Report

    Report Number
    1818910-2013-35706
    Event Type
    Injury
    Date Received
    December 11, 2013
    Date of Event
    November 22, 2013
    Report Date
    March 9, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS AGAINST LOT CODE 3149259 OR 3140546. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, IMMOBILITY AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    PPF ALLEGES INFECTION, METAL WEAR, AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646920 ASPHERE M SPEC 12/14 40 -2 FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US 3140546

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention