BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 43

    MDR report key: 2243429 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17844
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, LOT #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ACHES AND PAIN IN HER LEFT HIP AND GROIN, AN AUDIBLE CLICKING IN HER LEFT HIP AREA, PAIN IN HER LEFT HIP WHEN WALKING, STIFFNESS AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND ELEVATED LEVELS OF CHROMIUM AND COBALT BY BLOOD TESTS DATED (B)(6), 2010 AND (B)(6), 2011. UPDATE - (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ACHES AND PAIN IN HER LEFT HIP AND GROIN, AN AUDIBLE CLICKING IN HER LEFT HIP AREA, PAIN IN HER LEFT HIP WHEN WALKING, STIFFNESS AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND ELEVATED LEVELS OF CHROMIUM AND COBALT BY BLOOD TESTS DATED (B)(6) 2010 AND (B)(6) 2011. UPDATE - (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED DUE TO PAIN. UPDATE: (B)(4) 2011 - 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 43 FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL 2303691

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention