BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2900420 · Received January 7, 2013

    Report

    Report Number
    1818910-2013-00318
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    August 16, 2012
    Report Date
    August 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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)(4). 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT DEVELOPED PAIN, LOOSENING, A PSEUDOTUMOR AND METALLOSIS IN HER HIP. METAL FRAGMENTS WERE FOUND DURING REVISION SURGERY AND BONE GRAFTING WAS NEEDED BECAUSE OF THE EXTENSIVE DAMAGE CAUSED BY METALLOSIS.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB, AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6996 ASR ACETABULAR CUPS 52 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2484679

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention