BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 110V

    MDR report key: 23301968 · Received October 15, 2025

    Report

    Report Number
    0009617840-2025-00041
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    February 27, 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

    THE FOLLOWING REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H11. TECHNICAL REVIEW AND PHYSICAL EVALUATION: PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE). 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. (SEE SERVICING REPORT IN DILIGENCE LOG ATTACHMENTS). DHR REVIEW: 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. MEDICAL RECORDS, MEDICAL RECORDS WERE NOT PROVIDED. ROOT CAUSE: 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.

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020389 ROSA RECON PLATFORM 110V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male