BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2230469 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17047
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 9, 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

    THE (B)(4) WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 2010, AND THE (B)(4) 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 COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED INJURIES INCLUDING BUT NOT LIMITED TO GRINDING, METAL FLAKES IN AND AROUND THE SOCKET, FLUID, PAIN, SWELLING, LIMITED RANGE OF MOTION.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013-LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM CRAMPING IN HIP AND WALKING WITH A LIMP. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 55 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2646382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention