BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 23227487 · Received October 6, 2025

    Report

    Report Number
    0009617840-2025-00040
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K242864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2 FOREIGN: BELGIUM THE DEVICE WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BUT WILL BE EVALUATED ON SITE. 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: E1; E2; E3; H2; H3; H6; H11. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE FT (FORCE TORQUE) SENSOR CABLE WAS CONFIRMED BROKEN DURING ON-SITE EVALUATION AND CONTRIBUTED TO THE REPORTED EVENT. THE FT SENSOR CABLE WAS REPLACED AND RESOLVED THE REPORTED ISSUE. THE DEVICE HISTORY RECORD 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ROBOTIC ARM WAS DRIFTING AND WAS GIVING COLLISION ERRORS, DUE TO BROKEN FT (FORCE TORQUE) SENSOR CABLE. IT OCCURRED WHILE MAKING THE TIBIA CUT. THE DOCTOR DIDN¿T RELY ANYMORE ON THE VALUES THAT WERE SHOWN ON THE SCREEN, SO HE MADE THE 4-IN-1 HOLES FOR SETTING THE ROTATION WITH THE CONVENTIONAL MATERIAL. THERE WAS NO PATIENT HARM.

    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
    2420716 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown