BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 19070497 · Received April 9, 2024

    Report

    Report Number
    0001825034-2024-00969
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 8, 2024
    Report Date
    May 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). POSSIBLE LOTS: LOT: 66404406, EXP DATE: NOV 3, 2028, UDI: (B)(4), EXP DATE: NOV 3, 2023. LOT: 66404427 EXP DATE: NOV 3, 2028 UDI: (B)(4). EXP DATE: NOV 3, 2023. LOT: 374610, EXP DATE: SEP 21, 2027, UDI: (B)(4), EXP DATE: SEP 21, 2022. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 A MENISCUS REPAIR USING REPAIR DEVICES, ONE OF THE DISTAL TIP (LENGTH ABOUT 1 INCH) FRACTURED OFF IN THE POSTERIOR LATERAL MENISCUS. THE PIECE WAS RETRIEVED AND REMOVED FROM KNEE. THERE WERE ISSUES WITH 2 ADDITIONAL DEVICES, BUT DETAILS WERE UNCLEAR AS THE REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    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
    608170 JUGGERSTITCH CURVED IMPLANT SPORTS MED IMPLANTS MBI ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male