BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASR ACETABULAR CUP

    MDR report key: 2232190 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-16870
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(). 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 THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING INJURIES INCLUDING BUT NOT LIMITED TO: PAIN AND SUFFERING, SEVERE EMOTIONAL DISTRESS, HEAVY METAL POISONING/METALLOSIS, VISION IMPAIRMENT, PSEUDOTUMOR DEVELOPMENT, COGNITIVE DECLINE AND OTHER NEUROLOGICAL IMPAIRMENT, ORGAN DAMAGE, FATIGUE, HEADACHE, AND NAUSEA. IT IS FURTHER ALLEGED GIVEN THE TOXIC LEVELS OF COBALT AND CHROMIUM PRESENT IN PATIENT BLOODSTREAM (60.5 UG/L AND 48.8 UG/L RESPECTIVELY IN VARIOUS TESTING) AND TISSUE OVER AN EXTENDED PERIOD OF TIME, MEDICAL MONITORING WILL BE NECESSARY. PATIENT WILL BE HAVING THE RIGHT ASR HIP EXPLANTED AS SOON AS MEDICALLY ALLOWABLE FOLLOWING EXPLANT OF THE LEFT ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ASR ACETABULAR CUP ACETABULAR CUP KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention