BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STE NAVICULAR PLT LT SMALL

    MDR report key: 7117250 · Received December 14, 2017

    Report

    Report Number
    0001825034-2017-10962
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 8, 2017
    Report Date
    June 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 824672002, STE NAVICULAR PLT LT SMALL, 924860. 131212620, PEG FULLY THREAD 2.5MM X 20, 474820. 131212620, PEG FULLY THREAD 2.5MM X 20, 523140. 131212620, PEG FULLY THREAD 2.5MM X 20, 952920. 131212622, PEG FULLY THREAD 2.5MM X 22, 952930. 131212624, PEG FULLY THREAD 2.5MM X 24, 367070. 131212626, PEG FULLY THREAD 2.5MM X 26, 085530. 131212626, PEG FULLY THREAD 2.5MM X 26, 181900. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 A PATIENT UNDERWENT A PROCEDURE IN WHICH A FOOT PLATING SYSTEM WAS IMPLANTED. APPROXIMATELY 11 MONTHS LATER, THE PLATE FRACTURE WHILE THE PATIENT WAS IN REHABILITATION DUE TO EXCESSIVE REHABILITATION. NO INTERVENTION OR ADDITIONAL INFORMATION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895720 STE NAVICULAR PLT LT SMALL PLATE, FIXATION HRS ZIMMER BIOMET, INC. N/A 924860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other