BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2841824 · Received November 21, 2012

    Report

    Report Number
    1818910-2012-25417
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AND AGGRAVATION OF A PRE-EXISTING CONDITION. PAPERS ALSO ALLEGE EXCESSIVE CHROMIUM AND COBALT BLOOD LEVELS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT SUFFERED PAIN DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AND AGGRAVATION OF A PRE-EXISTING CONDITION. PAPERS ALSO ALLEGE EXCESSIVE CHROMIUM AND COBALT BLOOD LEVELS. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED PHYSICAL INJURY, BODILY IMPAIRMENT, A LACK OF MOBILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. THE PATIENT REPORTEDLY UNDERWENT A REVISION PROCEDURE IN WHICH THE ASR HIP WAS PARTIALLY EXPLANTED AND REPLACED WITH AN ANTIBIOTIC SPACER. APPROXIMATELY, 2 MONTHS LATER, THE REMAINING PORTION OF THE ASR HIP WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2762646

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R