BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2121917 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-10067
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    January 7, 2010
    Report Date
    May 10, 2011
    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
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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

    LITIGATION PAPERS ALLEGE: ON (B)(6), 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT. IN THE YEAR FOLLOWING HER SURGERY, PT EXPERIENCED DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, MOVE HER LEGS, AND RISE FROM A SEATED POSITION. PT UNDERWENT REVISION SURGERY TO REMOVE THE ASR HIP ON (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL NA 2621509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention