BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 4132719 · Received September 29, 2014

    Report

    Report Number
    9613350-2014-03918
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 21, 2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: PRODUCT WAS IMPLANTED IN 2009 ON UNKNOWN DATE AND WAS REVISED ON (B)(6) 2014 DUE TO LOOSENING, ELEVATED METAL IONS AND OSTEOLYSIS. NO X-RAYS WERE RECEIVED FOR EVALUATION. VISUAL EXAMINATION THE DUROM ACETABULAR COMPONENT HAD WHAT APPEARED TO BE A TOOL MARKING FROM PULLING THE CUP OUT. THERE IS A MARK ON THE OUTER POROUS COATING AND A CORRESPONDING DEEPER SCRATCH MARK INSIDE THE CUP AS WELL. THERE WERE ALSO LIGHTER SCRATCH MARKS INSIDE THE ACETABULAR COMPONENT. INSIDE THE HEAD WHERE THE NECK WOULD FIT IN SHOWED SIGNS OF CORROSION. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT 54/48 N ON AN UNKNOWN SIDE ON (EXACT DATE NOT REPORTED). THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO LOOSENING, ELEVATED METAL IONS AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604311 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2430299

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R