BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2761070 · Received September 26, 2012

    Report

    Report Number
    1818910-2012-75490
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    February 27, 2012
    Report Date
    August 27, 2012
    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
    KY, 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 BODILY IMPAIRMENT; DEBILITATING LACK OF MOBILITY; SEVERE PAIN AND SUFFERING, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. **UPDATE** (B)(4) 2012 LITIGATION PAPERS ALLEGE THAT THE PATIENT SUFFERED BODILY IMPAIRMENT; DEBILITATING LACK OF MOBILITY; SEVERE PAIN AND SUFFERING, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE FEMORAL HEAD. 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 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2649917

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention