BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 40 +8.5

    MDR report key: 3863568 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20546
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 31, 2011
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPDATE 6/25/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REIMPLANTED ON (B)(6) 2011 WITH COMPETITOR PRODUCTS AFTER HAVING AN INFECTED/PAINFUL HIP. SINCE INFECTION IS ALLEGED AND IT WAS CONFIRMED VIA MEDICAL RECORDS ALL IMPLANTS ARE BEING REPORTED. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS.

    Description of Event or Problem · 1

    (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ PATIENT REVISED FOR INFECTION. UPDATE REC'D (B)(4) 2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS. PPF ALSO REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2011 AFTER THE INFECTION WAS RESOLVE AND ALL TEMPORARY SPACERS WERE REMOVED AND REPLACED WITH COMPITITORS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337774 ASPHERE M SPEC 12/14 40 +8.5 HIP FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US 2940276

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention