BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 46/40 F

    MDR report key: 3810273 · Received April 28, 2014

    Report

    Report Number
    9613350-2014-03474
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON JULY 14, 2015 TO ENTER ADDITIONAL INFORMATION WHICH HAD BEEN RECEIVED ON JULY 11, 2015.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT 46/40 F.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED AN UNK DUROM US ACETABULAR COMPONENT ON THE RIGHT SIDE ON (B)(6) 2008 AND THE PT IS BEING MONITORED DUE TO UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254414 DUROM US ACETABULAR COMPONENT 46/40 F DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2395165

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other