BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASR UNI FEMORAL HEAD

    MDR report key: 2840017 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-28105
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    PATIENT SEEKING LEGAL ACTION. PPD AND STICKER SHEET WERE RECEIVED ON SEPARATE DATES. THE PPD WAS RECEIVED ON 10/24/2012 AND THE STICKER SHEET WAS RECEIVED ON 10/25/2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN AS A RESULT OF THE ASR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ASR UNI FEMORAL HEAD TOTAL HIP REPLACEMENT KWA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other