BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION(TM) DCF 4-IN-1 RESECTION GUIDE

    MDR report key: 1913098 · Received December 2, 2010

    Report

    Report Number
    1043534-2010-00495
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 28, 2010
    Report Date
    July 26, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY THE SURGEON DID NOT NOTICE THAT THE RESECTION GUIDE HAD TILTED INTO EXTENSION, AFTER THE TOP TWO ANTERIOR PINS WERE USED, AND NOTCHED THE FEMUR. HE REVISED TO A SIZE 3 STEM AND FINISHED THE SURGERY. SURGEON ADVISES PATIENT HAS SOFT BONES.

    Description of Event or Problem · 1

    ALLEGEDLY THE SURGEON DID NOT NOTICE THAT THE RESECTION GUIDE HAD TILTED INTO EXTENSION, AFTER THE TOP TWO ANTERIOR PINS WERE USED, AND NOTCHED THE FEMUR. HE REVISED TO A SIZE 3 STEM AND FINISHED THE SURGERY. SURGEON ADVISES PATIENT HAS SOFT BONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION(TM) DCF 4-IN-1 RESECTION GUIDE KNEE INSTRUMENT LXH WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1