BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2942751 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-01746
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013- SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS METALLOSIS AND A LOOSE CUP.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT SUFFERED PAIN, SUFFERING, DISABILITY, AND HAS BEEN EXPOSED TO CHROMIUM AND COBALT AS A RESULT OF THE ASR IMPLANT. THE PATIENT HAS BEEN INJURED PHYSICALLY AND EMOTIONALLY FROM EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT FOUND IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47152 ASR ACETABULAR CUPS 48 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2746964

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other