BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 3002026 · Received March 11, 2013

    Report

    Report Number
    9613350-2013-01406
    Event Type
    Other
    Date Received
    March 11, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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 CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. 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 FILED. 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 NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED, MEANWHILE DUE TO BUSINESS REASONS. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM US ACETABULAR COMPONENT 52/46 L ON (B)(6) 2008. THE PATIENT IS CURRENTLY BEING MONITORED DUE TO UNKNOWN SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102006 DUROM US ACETABULAR COMPONENT 52/46 L DUROM US ACETABULAR COMPONENT KWA ZIMMER GMBH 2418285

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other