BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOMET(R) COBALT CHROME FEMORAL HEAD

    MDR report key: 2993480 · Received March 7, 2013

    Report

    Report Number
    1043534-2013-00496
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2004
    Report Date
    January 29, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00495.

    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
    97804 ORTHOMET(R) COBALT CHROME FEMORAL HEAD HIP COMPONENT, CODE:LZO LZO WRIGHT MEDICAL TECHNOLOGY, INC. 027A058260

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention