BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD

    MDR report key: 1980801 · Received February 7, 2011

    Report

    Report Number
    1043534-2011-00057
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 4, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    PMA / PMN Number
    K893685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 06348047. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS IS THE SAME EVENT AS 1043534-2011-00056. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN DEVICE PROBLEM" IN ERROR. THIS EVENT SHOULD HAVE BEEN REPORTED (B)(4) - BROKEN."

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD HIP COMPONENT MRA WRIGHT MEDICAL TECHNOLOGY, INC. 06348047

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R