BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 23583061 · Received November 18, 2025

    Report

    Report Number
    3010266064-2025-00250
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER (B)(6), INTENDED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. SCREENSHOTS AND SYSTEM LOG FILES PROVIDED WERE REVIEWED WITH THE SOFTWARE SUPPORT TEAM. THE REPORTED PROBLEM WAS CONFIRMED. THE INSTANCE WAS ABLE TO BE REPRODUCED BY TAKING THE FEMUR KNEE CENTER INCORRECTLY. IT SEEMS LIKE THE SHIFTING OF FEMUR IMPLANT TOWARDS THE LATERAL SIDE IS DUE TO THE INCORRECT COLLECTION OF FEMUR KNEE CENTER POINTS. A COMPLAINT HISTORY REVIEW WAS PERFORMED BY PART NUMBER AND SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW BY SERIAL NUMBER WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE MOST LIKELY CAUSE OF THIS EVENT IS ASSOCIATED WITH USER ERROR AS THE FEMUR KNEE CENTER WAS TAKEN INCORRECTLY. THIS EVENT DOES NOT INDICATE ANY INCREASE IN RISK BEYOND WHAT IS ALREADY DOCUMENTED. GIVEN THAT THE ROOT CAUSE WAS USER ERROR BY AN OPERATOR AND THAT ALL SYSTEM SAFEGUARDS OPERATE CORRECTLY, NO DESIGN, USABILITY, IFU, OR TRAINING CHANGES ARE REQUIRED. THE RESIDUAL RISK REMAINS ACCEPTABLE, AND NO FURTHER ACTION IS NECESSARY. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTER THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY USING ONE (1) REAL INTELLIGENCE CORI, ALL FEMORAL MEASUREMENTS SHIFTED TO ONE CONDYLE. ARRAY MOVEMENT WAS DEFECTED BEFORE BURRING. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363778 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown