BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 110V

    MDR report key: 23301133 · Received October 15, 2025

    Report

    Report Number
    0009617840-2025-00042
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K242864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BUT WILL BE EVALUATED ON SITE. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: A1; A2; B5; D2B; D4; D9; G1; G3; H1; H3; H6. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) ON SEPTEMBER 25, 2025. THE FSE CONFIRMED THE REPORTED ISSUE OF THE ARM DRIFTING. THE FSE REPLACED THE FT SENSOR CABLE AND RESAT THE DAQ CARD, CORRECTING THE ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE SERIAL NUMBER WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE SERVICING/MAINTENANCE PROCESS CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS PREVIOUSLY SERVICED ON (B)(6) 2025, AND THE SYSTEM WAS FOUND TO BE IN WORKING ORDER. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM(S) AND PART AND LOT/SERIAL COMBINATION(S). AN OCCURRENCE CALCULATION WILL NOT BE COMPLETED FOR THE SIMILAR COMPLAINT FOR THE PART AND LOT/SERIAL AS THEY DO NOT HAVE THE SAME RISK SEQUENCE. 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 DURING SURGERY DUE TO A FORCE TORQUE SENSOR CABLE ISSUE. THE SURGERY WAS STILL COMPLETED ROBOTICALLY WITH NO PATIENT IMPACT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE ROBOTIC ARM DRIFTED DURING BONE CUTS; THE ARM HAD BEEN PROPERLY CALIBRATED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT PATIENT IMPACT. THE DRIFTING WAS NOTED INTRA-OPERATIVELY DURING CUTTING TASKS, AND SYSTEM LOGS WERE REQUESTED FOR INVESTIGATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337385 ROSA RECON PLATFORM 110V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female