BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 12814647 · Received November 15, 2021

    Report

    Report Number
    0001822565-2021-03286
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 22, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT : (B)(4). THIS PRODUCT IS SAME OR SIMILAR TO PMA/510(K) : K182964. ALL NECESSARY INFORMATION NEEDED TO CONDUCT AN INVESTIGATION INTO THIS INCIDENT HAS BEEN RECEIVED. AN INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE MADE AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6. THE ROSA KNEE SYSTEM SOFTWARE APPLICATION LOG FILES ASSOCIATED WITH THE REPORTED EVENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATION OF THE LOG FILES CONFIRMED THE REPORTED EVENT OF A 3MM OVER-RESECTION ON THE TIBIA (VALIDATION WAS AFFECTED) AND THE UNRECOVERABLE ROBOTIC ERROR DURING FINAL KNEE STATE. THE LOG FILE INVESTIGATION COULD NOT CONFIRM THE POSTERIOR UNDER-RESECTION NOR THE WRONG VARUS/VALGUS ON OF THE FEMUR. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE, THE STAUBLI CONTROLLER WOULD NOT RELIABLY COMMUNICATE WITH THE CLINICAL PC. THE ROBOTIC UNIT WAS REMOVED FROM THE FIELD AND ADDITIONAL TESTS WILL BE NEEDED TO UNDERSTAND THE CAUSE OF THE ROBOTIC ERROR. A DHR REVIEW WAS PERFORMED AND INDICATED THAT THERE WAS NO ISSUE LINKED TO THE REPORTED EVENT. THE INSTRUMENTS ARE CONFIRMED TO HAVE MET SPECIFICATIONS AND WERE DETERMINED TO BE CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT POTENTIAL CAUSES HAVE BEEN IDENTIFIED. THROUGH REASSESSMENT OF THIS EVENT, IT WAS IDENTIFIED AS BEING REPORTED IN ERROR. REPORTABILITY IS BASED ON HARM/INTERVENTION REQUIRED AND NOT A SPECIFIC RESECTION LEVEL. NO PATIENT IMPACT, MEDICAL INTERVENTION, OR SURGICAL INTERVENTION WAS REPORTED FOR THIS EVENT; THEREFORE, THE EVENT DOES NOT MEET THE REQUIREMENTS FOR A SERIOUS INJURY/ADVERSE EVENT AND IS CONSIDERED NOT REPORTABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA OVER RESECTION OCCURRED ON THE TIBIAL CUTS AT AROUND 3MM. IN ADDITION TO THE OVER RESECTION, ADDITIONAL RESECTIONS HAD TO BE MADE ON THE DISTAL FEMUR TO CORRECT A VALGUS CUT (AROUND 5 DEGREES) MADE WITH THE ROSA UNITS ASSISTANCE. THESE ADDITIONAL RESECTIONS MADE ON THE FEMUR LED TO AN UNKNOWN AMOUNT OF BONE BEING RESECTED FROM THE FEMUR THAT COULD NOT BE MEASURED. THE PROCEDURE WAS COMPLETED WITH NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711709 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown