BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD

    MDR report key: 3241546 · Received July 22, 2013

    Report

    Report Number
    1043534-2013-01184
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 17, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    PMA / PMN Number
    P030027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01183, 01185 01186, 01187.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. MEDIUM ACTIVITY LEVEL. SULFUR ALLERGIES. BMI: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340532 LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD HIP COMPONENT, CODE:MRA MRA WRIGHT MEDICAL TECHNOLOGY, INC. 09355102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention