BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET CRUCIATE STEM PUNCH

    MDR report key: 14592496 · Received June 2, 2022

    Report

    Report Number
    MW5110066
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 31, 2022
    Manufacturer
    ZIMMERBIOMET CHILE DFE
    Product Code
    HWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIOMET TIBIAL PUNCH HAD A PIECE THAT BROKE OFF AND WAS UNKNOWINGLY LEFT IN THE PT'S KNEE. IMMEDIATE POST OP XR DONE, IDENTIFIED THE FOREIGN OBJECT AND THE PT WENT BACK TO SURGERY TO HAVE THE PIECE REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161539 ZIMMER BIOMET CRUCIATE STEM PUNCH PUNCH, FEMORAL NECK HWP ZIMMERBIOMET CHILE DFE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention