BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2243462 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17779
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    August 9, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 THE FOLLOWING: IN APPROXIMATELY (B)(6) 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS, INCLUDING BUT NOT LIMITED TO, ELEVATED BLOOD METAL LEVELS, DISCOMFORT, SQUEAKING, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND SLEEP. PATIENTS ORTHOPEDIC SURGEON INVESTIGATED HIS SYMPTOMS AND IN APPROXIMATELY (B)(6) 2010 CONCLUDED THAT THE PROBLEMS WERE STEMMING FROM THE ASR HIP, BUT THAT THE PATIENT WAS NOT A CANDIDATE FOR REVISION SURGERY.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2011- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: IN APPROXIMATELY (B)(6) 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS, INCLUDING BUT NOT LIMITED TO, ELEVATED BLOOD METAL LEVELS, DISCOMFORT, SQUEAKING, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND SLEEP. PATIENT'S ORTHOPEDIC SURGEON INVESTIGATED HIS SYMPTOMS AND IN APPROXIMATELY (B)(6) 2010 CONCLUDED THAT THE PROBLEMS WERE STEMMING FROM THE ASR HIP, BUT THAT THE PATIENT WAS NOT A CANDIDATE FOR REVISION SURGERY. UPDATE: (B)(6) 2011 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2262543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention