BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULLAR COMPONENT 48/42 H

    MDR report key: 3202128 · Received June 18, 2013

    Report

    Report Number
    9613350-2013-01650
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION 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 RE-LAUNCH 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

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A DUROM US ACETABULAR COMPONENT 48/42 H ON THE LEFT SIDE ON (B)(6) 2009. TO DATE, THE PT HAS NOT BEEN REVISED. THE PT IS CURRENTLY BEING MONITORED DUE TO UNK REASONS. IT WAS ALSO REPORTED THAT THE PT HAD AVASCULAR NECROSIS, OSTEOARTHRITIS AND A LONG-STANDING EXPERIENCE WITH HIP PAIN BILATERALLY WITH MORE PAIN ON THE LEFT THAN ON THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276255 DUROM US ACETABULLAR COMPONENT 48/42 H DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2330892

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other