BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 3240782 · Received July 17, 2013

    Report

    Report Number
    9613350-2013-01735
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE REC'D FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 (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 ((B)(4)). THIS IS UNFORTUNATELY PT DEPENDENT AND CAN OCCUR WITH A LOW PERCENTAGE RATE WITH ALL KIND OF METAL ON METAL BASED PRODUCTS. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AS THE PT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON THE LEFT SIDE ON (B)(6) 2009. THE PT IS CURRENTLY BEING MONITORED DUE TO ELEVATED COCR LEVELS IN THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331983 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2479181

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other