BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2880079 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-28841
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    August 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REF. (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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SINCE THE SURGICAL IMPLANTATION OF THE ASR SYSTEM, THE PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT IN HER HIPS. AS A RESULT THE PATIENT UNDERWENT REVISION SURGERY, BUT CONTINUES TO EXPERIENCE PAIN IN HER HIPS. IT IS ALSO ALLEGED, THAT THE PATIENT HAS SUFFERED PERMANENT INJURIES AS A RESULT OF THE IMPLANTATION OF ASR HIP IMPLANTS. PATIENT IS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other