BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL EXPLANT "CUP CUTTER"

    MDR report key: 14574809 · Received June 1, 2022

    Report

    Report Number
    MW5110025
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ZIMMER BIOMET/ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A HIP REVISION, THE HANDLE OF THE SMALL EXPLANT "CUP CUTTER" BROKE. ON THE SECOND SET THE SCREW WOULDN'T WORK. THE SURGEON THEN USED CURVED OSTEOTOMES TO FINISH CUTTING THE ACETABULAR CUP. MORE BONE WAS REMOVED WITH THE OSTEOTOMES THAN IF THE CUP CUTTER WAS USED, BUT THIS DID NOT CHANGE THE COURSE OF THE SURGERY, NOR CAUSE ANY NOTICEABLE IMPACT TO THE PATIENT EITHER NOW OR IN THE FUTURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27122 SMALL EXPLANT "CUP CUTTER" ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET/ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female