BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 48/42 H

    MDR report key: 2218373 · Received August 8, 2011

    Report

    Report Number
    9613350-2011-00521
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CAUSE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. 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 DEVICES(S) BE RETURNED FOR EVALUATION 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 WAS REVISED DUE TO LOOSENING. ADDITIONALLY HIGH LEVEL OF CHROMIUM AND COBALT IONS IN PT'S BLOOD WERE DETECTED. CHROMIUM: 38 MG/L. COBALT: >100 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 48/42 H DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC. 2392120

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R