BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 56/50 CODE P

    MDR report key: 2320545 · Received October 26, 2011

    Report

    Report Number
    9613350-2011-00709
    Event Type
    Injury
    Date Received
    October 26, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 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 (B)(4) 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 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. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH ELEVATED LEVEL OF CHROME AND COBALT IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 56/50 CODE P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC. 2186977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other