BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 23780027 · Received December 11, 2025

    Report

    Report Number
    0009617840-2025-00044
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 14, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024582682
    PMA / PMN Number
    K242864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A3A; B5; D2B; D4; D9; E2; G1; G3; H1; H3; H6. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. A VIDEO WAS PROVIDED SHOWING THE ROSA ARM POSITIONING ITSELF AWAY FROM THE PATIENT KNEE AS REPORTED. THE ARM WAS FULLY EXTENDED, CONFIRMING THE EVENT AS REPORTED. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) ON NOVEMBER 20, 2025. UNKNOWN ROBOTIC ERRORS WERE CONFIRMED AND THE FSE RAISED THE ISSUE WITH SERVICE ENGINEER SUPPORT THROUGH SES-10134. PER RECOMMENDATION FROM SERVICE ENGINEERING SUPPORT, THE FSE REPLACED THE FORCE SENSOR CABLE, THE FOOT PEDAL, AND THE DAQ CARD IN THE HSDK PC. THESE REPLACEMENTS RESOLVED THE ISSUE, AND THE UNIT WAS FULLY OPERATIONAL AFTER THE SERVICING INTERVENTION. THE SES TEAM CONFIRMED THE ERRORS IN THE LOGS RELATED TO THE FORCE SENSOR ERROR AND VIGILANCE DEVICE ERRORS AS WELL AS SINGULARITY ERRORS. FURTHER ANALYSIS BY THE SME TEAM CONFIRMED AN ISSUE WITH THE FORCE SENSOR CABLE OR DAQ CARD COULD CAUSE DRIFTING AND EXCESSIVE FORCE ERRORS. THE LOGS WERE CONSISTENT WITH THE REPORTED ISSUE AND THE PROBLEM WAS LIKELY CAUSED BY THE HARDWARE ISSUES. REVIEW OF THE DHR FOUND REVIEW OF THE PREVIOUS REPAIR RECORD IDENTIFIED UNRELATED REPAIRS TO THE REPORTED EVENT. THE DEVICE WAS TESTED AND FOUND TO BE FUNCTIONING TO SPECIFICATIONS PRIOR TO RELEASE TO THE CUSTOMER. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION(S). 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE ROBOTIC SYSTEM DISPLAYED AN EXCESSIVE FORCE OUTPUT ERROR DURING SETUP AND SUBSEQUENTLY MALFUNCTIONED INTRA-OPERATIVELY, LEADING THE PROCEDURE TO BE COMPLETED CONVENTIONALLY WITHOUT THE ROBOT. DURING INITIAL SETUP, THE ERROR MESSAGE APPEARED BEFORE THE ROBOT ARM WAS EXTENDED TO ATTACH THE FIRST INSTRUMENT. MULTIPLE RESTARTS, INCLUDING A POWER DISCONNECTION, WERE ATTEMPTED. SUPPORT ADVISED CHECKING THE FORCE SENSOR CABLE; AFTER TIGHTENING THE CABLE, AN AUTOMATIC RECALIBRATION OCCURRED, AND SETUP CONTINUED WITH PHONE SUPPORT CONFIRMING CORRECT CALIBRATION THROUGH DRAPING. INTRA-OPERATIVELY, THE ROBOT ARM DRIFTED AND ACTIVELY MOVED AWAY FROM THE TIBIA. IN COLLABORATION MODE, THE ARM EXTENDED FULLY ON ITS OWN AND REQUIRED A RESET VIA THE HOME BUTTON. THE PROCEDURE WAS THEN COMPLETED USING CONVENTIONAL TECHNIQUES WITHOUT THE ROBOTIC SYSTEM. THE PATIENT HAD NO KNOWN IMPACT OR CONSEQUENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNKNOWN DATE, AN OPERATING ROOM NURSE REPORTED A ROBOT ERROR INDICATING EXCESSIVE FORCE OUTPUT PRIOR TO EXTENDING THE ROBOT ARM TO ATTACH THE FIRST INSTRUMENT. DURING SETUP, TWO RESTARTS, INCLUDING A POWER DISCONNECTION, HAD ALREADY BEEN PERFORMED. CLINICAL SUPPORT ADVISED CHECKING THE FORCE SENSOR CABLE; THE CABLE WAS TIGHTENED, WHICH TRIGGERED AN AUTOMATIC RECALIBRATION. SETUP THEN CONTINUED SUCCESSFULLY, AND PHONE SUPPORT REMAINED UNTIL DRAPING, CONFIRMING CORRECT CALIBRATION. IT WAS NOTED THAT THE SAME ERROR HAD OCCURRED DURING A PRIOR SURGERY; NO FURTHER DETAILS WERE PROVIDED. DURING THE SUBSEQUENT SURGERY, THE ROBOT ARM MALFUNCTIONED AGAIN, DRIFTING AND ACTIVELY MOVING AWAY FROM THE TIBIA. IN COLLABORATION MODE, THE ARM EXTENDED FULLY ON ITS OWN AND COULD ONLY BE RESET USING THE HOME BUTTON. THE PROCEDURE WAS CONVERTED AND COMPLETED USING CONVENTIONAL TECHNIQUES WITHOUT ROBOTIC ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555243 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 1.4.4.25 00889024582682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown