BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 49

    MDR report key: 2855047 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-24234
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    August 22, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K032659
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT THE PATIENT SUFFERED PAIN AND SUFFERING, A CLUNKING SOUND IN HER HIP, AND SEVERE PHYSICAL INJURIES AS A RESULT OF IMPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT SUFFERED PAIN AND SUFFERING, A CLUNKING SOUND IN HER HIP, AND SEVERE PHYSICAL INJURIES AS A RESULT OF IMPLANTATION OF THE ASR HIP IMPLANT. **UPDATE** (B)(4) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR FEM IMPLANT SZ 49 FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL 2340246

    Patients

    Seq Age Sex Outcome Treatment
    1 Other