BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED

    MDR report key: 24332596 · Received February 13, 2026

    Report

    Report Number
    0001825034-2026-00334
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 8, 2026
    Report Date
    February 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00887868575068
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN, THE EVENT OCCURRED IN JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 110024773N (2003402). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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 THAT DURING THE SURGERY, THE NEEDLE OF THE COMPLAINT PRODUCT'S DEVICE WAS FRACTURED DURING USE. THEREFORE, THE SURGEON USED A BACK UP OF THE SAME PRODUCT FOR THE SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395985 JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. 2003402 00887868575068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.