BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 20072608 · Received August 26, 2024

    Report

    Report Number
    0001825034-2024-02084
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EXACT EVENT DATE IS UNKNOWN HOWEVER WAS REPORTED TO HAVE OCCURRED IN JULY 2024. D4: LOT: IT WAS REPORTED THAT THE EXACT LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN AS MULTIPLE LOTS HAD BEEN USED DURING THE PROCEDURE. THERE ARE THREE POTENTIAL DEVICES THAT CAUSED THE REPORTED EVENT: POTENTIAL LOT (1), QTY 2: (B)(4). EXPIRATION DATE: OCT 25, 2028. UDI: (B)(4). POTENTIAL LOT (2): 66526684. EXPIRATION DATE: JAN 19, 2029. UDI: (B)(4). G2: FOREIGN: GERMANY. H4: MANUFACTURING DATES BY LOT: LOT# 66391047: MANUFACTURING DATE NOV 21, 2023 LOT# 66526684: MANUFACTURING DATE FEB 15, 2024 CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TENDON REPAIR PROCEDURE, THE NEEDLE OF THE INSERTER INSTRUMENT FRACTURED IN THE KNEE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES TO REMOVE THE FRACTURED PIECES OF THE DEVICE HOWEVER NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29291 JUGGERSTITCH CURVED IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose