BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 3875195 · Received May 30, 2014

    Report

    Report Number
    9613350-2014-03583
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 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 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 AND / OR THE DEVICE(S) 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM US ACETABULAR COMPONENT 56/50 P ON THE RIGHT SIDE ON (B)(6) 2009. REVISION SURGERY IS PLANNED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319300 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2437915

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other