BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2923127 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-01185
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    August 15, 2013
    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

    **UPDATE** 2/5/2013 - PPD RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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 ALLEGED THE PATIENT SUFFERED PAIN, DECREASED MOBILITY, AND INCREASED BLOOD METAL ION LEVELS AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM STIFFNESS AND WEAKNESS THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28087 ASR ACETABULAR CUPS 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2516200

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other