BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 4092225 · Received August 20, 2014

    Report

    Report Number
    9613350-2014-03802
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    June 27, 2013
    Report Date
    July 28, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THESE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF DUROM/LDH SYSTEM. IT WAS REPORTED BY THE PATIENT'S COUNSEL THAT HIS CLIENT RECEIVED A LEFT HIP IMPLANT ON (B)(6) 2009 AND A REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2013 DUE TO PAIN, SWOLLEN HIP AND ELEVATED COCR IN THE BLOOD. THE LAWYER REPORTED THAT THE IMPLANTATION OF THE DAM LDH SYSTEM LED TO A MEDICALLY REQUIRED RETREATMENT. ZIMMER GMBH CANNOT ASCERTAIN FROM THE INFORMATION RECEIVED AS TO WHAT CAUSED THE REPORTED EVENTS, BUT THE DATE OF THE ORIGINAL IMPLANTATION SUGGESTS THAT THIS CASE COULD BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN OCTOBER 2009. NO DEVICES WERE RECEIVED FOR INVESTIGATION HENCE THE TECHNICAL INVESTIGATION COULD NOT BE CONDUCTED. SINCE A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION RECEIVED, THE MOST REASONABLE ISSUES ARE CORROSION AT THE STEM/TAPER ADAPTER, LACK OF BONE ONGROWTH OF THE CUP. LOOSE CUPS, PAIN. OSTEOLYSIS, AND MILKY FLUID IN THE JOINT SPACE. THESE ISSUES ARE KNOWN AND HAVE BEEN ADDRESSED IN THE (B)(4) CAPA INITIATED BY ZIMMER IN OCTOBER 2009. FURTHER ON, THERE IS NO FUTURE RISK IN THE USE OF DUROM ACETABULAR COMPONENT AS IT IS NOT SOLD ANYMORE AND THE CERTIFICATE FOR DUROM ACETABULAR COMPONENT CE 524054 HAS ALREADY EXPIRED ON 04/19/2014, AND WILL NOT BE RENEWED. HENCE, ZIMMER GMBH WILL CONSIDER THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON THE LEFT SIDE ON (B)(6) 2009. THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN, SWELLING AND ELEVATED COCR IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500772 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R