BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 21379531 · Received February 13, 2025

    Report

    Report Number
    0001825034-2025-00363
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 9, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). BOTH LOT NUMBERS WERE USED IN THE PROCEDURE AND IT HAS NOT YET BEEN CONFIRMED WHICH IS THE LOT THAT MALFUNCTIONED: LOT #: 0951231, LOT #: 0936491. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT 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, D4, G3, G6, H2, H3, H4, H6, H11 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 RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS NOT CONFIRMED. 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 THAT DURING SURGERY THAT THE SECOND ANCHOR DID NOT DEPLOY. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO RECORD OF A DELAY. DUE DILIGENCE IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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
    1126875 JUGGERSTITCH CURVED IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. 0951231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown