BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 110V

    MDR report key: 24998727 · Received April 27, 2026

    Report

    Report Number
    0009617840-2026-00015
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024511026
    PMA / PMN Number
    K251314
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AN INVESTIGATION INTO THE REPORTED MALFUNCTION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL 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; A3; B5; E1; E2; E3; G3; H2; H6. AN INVESTIGATION INTO THE REPORTED MALFUNCTION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROSA KNEE CASE, A FORCES SENSOR ERROR AND UNINTENDED ROBOTIC ARM DRIFTING WAS EXPERIENCED. NO HARM OR IMPACT REPORTED. INVESTIGATION LOGS FOUND FAULTY FT SENSOR CABLE AND DAQ CARD CAUSING DRIFTING INTERMITTENTLY. A FIELD SERVICE ENGINEER WENT ON SITE TO REPLACE THE FAULTY DAQ CARD AND CABLE. THE ENGINEER CONFIRMED THE NEW DAQ CARD IN NIMAX, FT SENSOR TESTED, ARM ACCURACY TEST, AND APPLICATIVE TEST ALL PASSED. THE UNIT IS FULLY FUNCTIONAL. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROSA KNEE CASE, A FORCES SENSOR ERROR AND UNINTENDED ROBOTIC ARM DRIFTING WAS EXPERIENCED. THE PROCEDURE WAS COMPLETED UTILIZING THE ROBOT WITH NO FURTHER ISSUES. A SLIGHT DELAY OCCURRED ONCE A CALIBRATION ERROR APPEARED, BUT IT WAS CLEARED AND THE CASE PROCEEDED. NO PATIENT IMPACT. INVESTIGATION LOGS FOUND FAULTY FT SENSOR CABLE AND DAQ CARD CAUSING DRIFTING INTERMITTENTLY. A FIELD SERVICE ENGINEER WENT ON SITE TO REPLACE THE FAULTY DAQ CARD AND CABLE. THE ENGINEER CONFIRMED THE NEW DAQ CARD IN NIMAX, FT SENSOR TESTED, ARM ACCURACY TEST, AND APPLICATIVE TEST ALL PASSED. THE UNIT IS FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274149 ROSA RECON PLATFORM 110V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 00889024511026

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female