BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SS COMPRESSION HIP SCREW LAG SCREW

    MDR report key: 5959738 · Received September 19, 2016

    Report

    Report Number
    0001825034-2016-03704
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    February 27, 2016
    Report Date
    August 31, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    KTT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET IN (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K972629. EXAMINATION OF RETURNED DEVICE AND DEVICE HISTORY RECORDS FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL REVIEW OF THE LAG SCREW SHOWS MARKS/SCRATCHES ON THE SURFACE; WHICH IS EXPECTED AS THE PART WAS IMPLANTED AND THEN EXPLANTED DAYS LATER. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION OF A HIP FRACTURE SYSTEM TWO DAYS POST-IMPLANTATION DUE TO THE LAG SCREW BEING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613577 SS COMPRESSION HIP SCREW LAG SCREW APPLIANCE, FIXATION KTT BIOMET TRAUMA N/A RE1222 A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R