BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2218356 · Received August 8, 2011

    Report

    Report Number
    9613350-2011-00512
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC DEVICE HAS NOT BEEN RETURNED FOR REVIEW AND THE LOT NUMBER HAS NOT BEEN PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. A CLEAR CORRELATION BETWEEN THE DEVELOPED METAL ALLERGY OF THE PT AND THE PRODUCT CANNOT BE RULED OUT AS IT IS ALREADY KNOWN FOR SIMILAR METAL ON METAL DEVICES FROM LITERATURE (K. DE SMET, R. DE HANN, A. CALISTRI, P.A. CAMPBELL, E. EBRAMZADEH, C. PATTYN, AND H.S. GILL. METAL ION MEASUREMENT AS A DIAGNOSTIC TOOL TO IDENTIFY PROBLEMS WITH METAL-ON-METAL HIP RESURFACING. JBJS AM. 2008; 90: 202-208). OUR INVESTIGATION HAS SHOWN THAT METAL ION MEASUREMENTS FOR THE DUROM SYSTEM ARE COMPARABLE TO OTHER MOM DEVICES IN THE MARKET. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE (S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TOTAL HIP ARTHROPLASTY IN (B)(6) 2007. THE PT EXPERIENCED PAIN AND "CHROMIUM LEAKING INTO HIS BLOOD" IN 2011. REVISION WAS DONE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R