BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+8.5

    MDR report key: 2862194 · Received December 7, 2012

    Report

    Report Number
    1818910-2012-83258
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    September 20, 2012
    Report Date
    April 11, 2013
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2012-21464. THIS REPORT, 1818910-2012-83258, WILL BE REJECTED; 1818910-2012-21464 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    (B)(4) SUBMITTED BY HOSPITAL STATES THAT PATIENT WAS REVISED TO ADDRESS GROIN PAIN, ELEVATED COBALT ION LEVELS, METALLOSIS, AND CORROSION AT THE LINER/CUP INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+8.5 FEMORAL HEAD LPH DEPUY INTL., LTD. 2635368

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other