BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 23489099 · Received November 6, 2025

    Report

    Report Number
    0009617840-2025-00043
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    June 12, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024582682
    PMA / PMN Number
    K242864
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2: AUSTRALIA . PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE). THE FSE FOUND THAT THE FORCE SENSOR CABLE WAS MALFUNCTIONING, CONTRIBUTING TO THE REPORTED ERRORS, BUT HAD NO VISIBLE DAMAGE OBSERVED. THE FSE REPLACED THE FORCE SENSOR CABLE, AND THE UNIT WAS FULLY OPERATIONAL. THE UNIT THEN RECEIVED A SOFTWARE UPGRADE TO PLATFORM L AND WAS RELEASED FOR CLINICAL USAGE AFTER PASSING ALL TESTING. REVIEW OF THE PREVIOUS REPAIR RECORD IDENTIFIED UNRELATED REPAIRS TO THE REPORTED EVENT. THE DEVICE WAS TESTED AND FOUND TO BE FUNCTIONING SPECIFICATIONS PRIOR TO BEING RELEASED TO THE CUSTOMER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION CURRENTLY 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 TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONSTANT COLLISION ERROR MESSAGES WERE EXPERIENCED WHILE THE ROSA ROBOTIC ARM WAS MOVING, AND BY ITSELF DURING COLLABORATION MODE. ACCURACY WAS NOT AFFECTED. THERE WAS A 20 (TWENTY) MINUTE DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702456 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25 00889024582682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown