BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FIXED I-BEAM TIBIAL PLATE INTERLOK - WITH LOCKING BAR

    MDR report key: 7422803 · Received April 11, 2018

    Report

    Report Number
    0001825034-2018-02533
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCT - VAN PS OPEN INTL FEM-RT 72.5 CATALOG # 183113 LOT# J3815863U, SERIES A PAT THN 34 3 PEG CATALOG# 184786 LOT# 602490, VNGD PS TIB BRG 10X71/75 MM CATALOG# 183640 LOT# 926880 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO DISSOCIATION OF THE LOCKING BAR ONE MONTH POST IMPLANTATION. THE LOCKING BAR WAS REPLACED AND ALL OTHER COMPONENTS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263250 BIOMET FIXED I-BEAM TIBIAL PLATE INTERLOK - WITH LOCKING BAR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6131396

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R