BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE METAL LINER

    MDR report key: 3093779 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-16563
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, LACK OF MOBILITY AND HIGH LEVELS OF METAL IONS.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS. AFTER REVIEW OF MEDICAL RECORD FOR MDR REPORTABILITY, PATIENT WAS REVISED DUE TO SEVERE LOCAL TISSUE REACTION WITH LARGE AMOUNT OF FLUID WITH FLUID ULCER PRESSURE, ABNORMAL MEMBRANOUS BURSA AND SMALL AMOUNT OF BONE RESORPTION/OSTEOLYSIS AROUND THE ACETABULUM. IT WAS ALSO STATED THAT HER METAL ION LEVELS WERE ELEVATED ABOVE 20. REVISION NOTES STATED THAT SHE ALSO HAS AN ABNORMAL BURSA THAT IS BROWNISH AND GRAYISH IN COLOR. ADDED DOB, DOR, LAWYER, SURGEON, REVISION HOSPITAL AND LAW FIRM. CORRECTED PATIENT NAME. THERE IS NO STICKER SHEETS INDICATED IN THE PPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196838 UNKNOWN DEPUY PINNACLE METAL LINER TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention