BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 22871846 · Received August 22, 2025

    Report

    Report Number
    0009617840-2025-00038
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    February 3, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K242864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2 FOREIGN: ITALY . THE PROVIDED PICTURES DISPLAY WARNING FOR THE AUTO-CALIBRATION SENSOR, CALIBRATION GRAPH VALUES WITH FOUR OF THE VALUES FOR (FX, FY, FZ AND TX) ARE NEGATIVE AND TWO OF THE VALUES FOR (TY AND TZ) ARE IN POSITIVE AND SENSOR CALIBRATION ERROR, CONFIRMING THE REPORTED EVENT AND SUBSEQUENT FSE (FIELD SERVICE ENGINEER) EVALUATION WAS THAT THE ATI VALUES WERE ABNORMAL. DURING SERVICING, THE FSE FOUND THAT THE ATI DAQ VALUES WERE ABNORMAL, AND DETERMINED THE ISSUE WAS CAUSED BY THE FORCE SENSOR CABLE. THE FSE REPLACED THE SENSOR TO ROBOT ARM CABLE SUCCESSFULLY, COMPLETED THE APPLICATIVE TEST AND FINALS CHECK WHICH ALL PASSED AND THE UNIT WAS READY FOR CLINICAL USE. REVIEW OF THE DEVICE HISTORY RECORD/SERVICING HISTORY IDENTIFIED NO DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 THERE WAS A COLLISION DETECTED DURING REGISTRATION PHASE, ROBOTIC ARM WAS FREE TO MOVE, AND NO FORCES WERE APPLIED ON THE ARM. SURGERY WAS CONVERTED TO MANUAL. THERE WAS NO IMPACT OR HARM TO THE PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558337 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown