BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-SCREW BUTTRESS THREAD

    MDR report key: 338634 · Received June 21, 2001

    Report

    Report Number
    1825034-2001-00057
    Event Type
    Injury
    Date Received
    June 21, 2001
    Date of Event
    April 26, 2001
    Report Date
    June 21, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE ARTHROPLASTY PERFORMED 03/2001. RETROGRADE NAIL INSERTED 03/2001, DUE TO FEMUR FRACTURE. PT RETURNED WITH DRAINAGE AND UPON EXAMINATION IT APPEARED THAT SCREW WAS BACKING OUT. SURGERY PERFORMED 04/2001, FOR DEBRIDEMENT AND REMOVAL OF SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28351 TI-SCREW BUTTRESS THREAD FIXATION, TRAUMA, COMP. HSB BIOMET, INC. NA 699960

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R