BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE INSERTER

    MDR report key: 17652129 · Received August 30, 2023

    Report

    Report Number
    0001822565-2023-02355
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 24, 2023
    Report Date
    January 3, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024246423
    PMA / PMN Number
    K172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: PSN TIB NP STM 5 DEG SZ D R CATALOG # 42-5320-067-02 LOT # 66034827. MC VITE ARTICULAR SURFACE 10 MM CATALOG # 42-5121-044-10 LOT # 65280762. G2: DENMARK. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF REPEATED USE WITH DISCOLORATION AND THE TIP OF THE UNIT WAS FRACTURED OFF. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 THE DEVICE FRACTURED AND THIS RESULTED IN THAT THE IMPLANTS DROPPING TO THE FLOOR DURING PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    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
    1679503 TIBIAL ARTICULAR SURFACE INSERTER INSTRUMENT KNEE MBH ZIMMER BIOMET, INC. N/A 64941593 00889024246423

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown