BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WMT SLT TAPER COBALT-CHROME FEMORAL HEAD

    MDR report key: 2073202 · Received April 29, 2011

    Report

    Report Number
    1043534-2011-00181
    Event Type
    Injury
    Date Received
    April 29, 2011
    Report Date
    March 27, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 07347880. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE #3: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500 HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00179, 00180.

    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 WMT SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 07347880

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R