BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 50

    MDR report key: 2962452 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-03824
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    February 1, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. REF. (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

    OPERATIVE REPORT RECEIVED FOR PATIENTS RIGHT HIP PRIMARY SURGERY. ALSO, ON (B)(4) 2012, SUMMONS ONLY WAS RECEIVED - NO LITIGATION INCLUDED. UPDATE: (B)(6) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2013- LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, WEAKNESS, INSTABILITY, AND LIMITED MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65918 ASR 300 SPIKED CUP SIZE 50 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2747899

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other