BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN 125 DEG 9MM X 180MM

    MDR report key: 15665731 · Received October 25, 2022

    Report

    Report Number
    0001825034-2022-02410
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    August 10, 2022
    Report Date
    January 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868037962
    PMA / PMN Number
    K100238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN SOURCE: FRANCE. CUSTOMER HAS 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 REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT REMAINS IMPLANTED

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D6: PRODUCT WAS NOT EXPLANTED. PROPOSED CODE: MECHANICAL (G04) - IM NAIL. SUPPLIER LOT NUMBER 5982107 WAS PROVIDED. THIS WAS ISSUED TO ZB LOTS 246460, 246440 AND 030300. AS SUCH LOT IS UNKNOWN AND ALL 3 LOTS WILL BE INVESTIGATED. MANUFACTURE AND EXPIRATION DATE FOR LOTS: M246460 05/06/2022-05/06/2032. M246440 05/22/2022-05/22/2032. M030300 04/20/2022-04/20/2032. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NAIL FRACTURE. THE END BROKEN NAIL COULD NOT BE REMOVED. IT REMAINS IN PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743239 HFN 125 DEG 9MM X 180MM ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A 246460, 246440, 030300 00887868037962

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention| H