BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL ALIGNMENT GUIDE

    MDR report key: 216688 · Received March 26, 1999

    Report

    Report Number
    2952369-1999-00002
    Event Type
    Malfunction
    Date Received
    March 26, 1999
    Date of Event
    March 1, 1999
    Report Date
    March 26, 1999
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE BUSHING OF THE FEMORAL ALIGNMENT GUIDE SEIZED AND WOULD NOT ALLOW PROPER ALIGNMENT OF THE T-ROD. CONSEQUENTLY, THE INSTRUMENT WAS NOT USED BY THE SURGEON. THE RESULT WAS A MINOR SURGICAL DELAY AND LESS THAN OPTIMAL ALIGNMENT OF THE SAW GUIDE USED TO PERFORM THE FEMORAL BONE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL ALIGNMENT GUIDE ALIGNMENT GUIDE (INSTRUMENT) LXH HAYES MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other FEMORAL HIP IMPLANT.