BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2240831 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17700
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    LITIGATION PAPERS ALLEGE: PATIENT HAS SUFFERED SEVERE PAIN, CRUNCHING OR POPPING NOISES IN HIP REGION, DIFFICULTY STANDING OR WALKING, HIP FRACTURES OR DISLOCATIONS, FATIGUE, TISSUE INFLAMMATION, INFECTION, NECROSIS AND METALLOSIS. IT IS UNKNOWN WHETHER OR NOT PATIENT HAS BEEN REVISED.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOI, DOB, AND SIDE INFORMATION. PART & LOT FOR CUP WAS ALSO IDENTIFIED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT WAS UPDATED ON (B)(6) 2013.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013. SALES REP REPORTED REVISION TO ADDRESS A LOOSENED ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2300350

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention