BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPNENT

    MDR report key: 2845002 · Received November 13, 2012

    Report

    Report Number
    9613350-2012-01076
    Event Type
    Other
    Date Received
    November 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PATIENT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CLEAR CORRELATION BETWEEN THE DEVELOPED METAL ALLERGY OF THE PATIENT AND THE PRODUCT CANNOT BE RULED OUT AS IT IS ALREADY KNOWN FOR SIMILAR METAL ON METAL (MOM) DEVICES FROM LITERATURE. OUR INVESTIGATION HAS SHOWN THAT METAL ION MEASUREMENTS FOR THE DUROM SYSTEM ARE COMPARABLE TO OTHER MOM DEVICES IN THE MARKET. AN ALLERGIC REACTION CAN BE AN INHERENT POST-OPERATIVE SIDE EFFECT AS STATED IN ZIMMER'S IFU (D011500213). THIS IS UNFORTUNATELY PATIENT DEPENDANT AND CAN OCCUR WITH A LOW PERCENTAGE RATE WITH ALL KIND OF METAL ON METAL BASED PRODUCTS. SHOULD ADDITIONAL INFORMATION INCLUDING THE FINAL INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED AN ACETABULAR CUP, LEFT SIDE AND THE PATIENT IS CURRENTLY MONITORED DUE TO ELEVATED LEVEL OF COCR IN HER BLOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other