BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN JUGGERKNOT

    MDR report key: 23427237 · Received October 30, 2025

    Report

    Report Number
    0001825034-2025-03417
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 14, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: FRANCE. G2: LITERATURE: CHOON CHIET HONG, CHRISTEL CHARPAIL, CHARLES KON KAM KING, AND STEPHANE GUILLO 2024. ALL-INSIDE ENDOSCOPIC CLASSIC BROSTROM--GOULD TECHNIQUE. THE AMERICAN JOURNAL OF SPORTS MEDICINE, 2024;52(13):3330¿3338. DOI: 10.1177/03635465241285892. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO LACK OF PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT REPORTS PAIN AND STIFFNESS ON AN UNKNOWN DATE. THE PATIENT HAS NOT RECEIVED TREATMENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170637 UNKNOWN JUGGERKNOT IMPLANT/SPORTS MEDICINE MBI ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other