BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPLANT SIZE 46

    MDR report key: 2233256 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-17142
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    January 18, 2011
    Report Date
    August 5, 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

    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

    PATIENT FACT SHEET (PFS) FORM RECEIVED WHICH IDENTIFIED DATE OF BIRTH AND PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 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

    LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OUR ABOUT (B)(6) 2010, PATIENT BEGAN SUFFERING DISCOMFORT, PAIN, AND A FEELING OF INSTABILITY IN HIS HIP. HIS PAIN CONTINUED TO WORSEN CONSIDERABLY AND SIGNIFICANTLY IPAIR HIS ABILITY TO WALK, STAND, WORK AND EVEN SLEEP. THIS, COMBINED WITH PATIENTS INCREASED METAL ION LEVELS AND PATIENTS BONE SCAN, WHICH SHOWED CONCERN FOR LOOSENING, REQUIRED PATIENT TO UNDERGO A HIP REIVION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPLANT SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2317628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention