BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2935427 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-01252
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    April 8, 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY ON DUE TO PAIN, FLUID, AND CUP LOOSENING.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PHYSICAL INJURY, PAIN,BODILY IMPAIRMENT AND HIGH LEVELS OF TOXIC METAL IN THE BLOOD STREAM AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40612 UNKNOWN DEPUY ASR ACETABULAR CUP ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2247012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other