BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 13843836 · Received March 21, 2022

    Report

    Report Number
    0009617840-2022-00015
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 22, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SAME/SIMILAR TO PRODUCT 510(K): K182964. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). SAME/SIMILAR TO PRODUCT 510(K): K182964. G2: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN AUSTRALIA. THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND CORRECTIONS FROM THE COMPLETED INVESTIGATION. TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE ROBOTIC SYSTEM LOG FILES WERE SENT BACK FOR INVESTIGATION AND ANALYZED BY A SUBJECT MATTER EXPERT (SME). THE REPORTED ISSUE CANNOT BE CONFIRMED BY THE AVAILABLE DATA IN THE LOGS. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS AND THROUGH CONTACT WITH THE PER AUTHOR: ¿ IMAGE BASE CASE. INTRA-OP LANDMARKS WERE LOADED ON THE BONE MODEL. THE TIBIA PROXIMAL CANAL ENTRY WAS MORE MEDIAL THAN PRE-OP PLANNING. ¿ BOTH BONES REFERENCES WERE PINNED INSIDE THE INCISION, POTENTIALLY CREATING ADDITIONAL STRESS AROUND THE PIN DUE TO THE SOFT TISSUE PRESSURE AND INCREASING THE CHANCE OF A LOOSE REFERENCE. ¿ THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PER AUTHOR PROVIDED PICTURES OF THE DROP ROD, WHICH IS PART OF THE STANDARD INSTRUMENTATION TO ASSESS QUALITATIVELY THE VARUS-VALGUS (V/V) ALIGNMENT OF THE TIBIA PROXIMAL RESECTION. THE PHOTOS WERE TAKEN TO SHOW THE ALIGNMENT OF THE TIBIAL CUT, WITH THE TRIAL TIBIAL BASEPLATE IN, BEFORE, THE TIBIA RECUT WITH MANUAL INSTRUMENTATION. THE DROP ROD WAS INSTALLED INTO THE PIN HOLES MADE, AND ACCORDING TO PER AUTHOR, THE DROP ROD POINTED TO THE DISTAL FIBULA. AS THE PHOTOS WERE TAKEN FROM THE SIDE, IT IS IMPOSSIBLE TO ASSESS FROM THE PICTURE PROVIDED THE V/V ALIGNMENT MEASURED BY THE SURGEON WITH THE DROP ROD. THE TIBIA TRACKER WAS REMOVED AT THE MOMENT TO INSTALL THE DROP ROD. THE PER AUTHOR ALSO PROVIDED TWO PICTURES OF PRE-OPERATIVE X-RAYS TO SHOW THE SURGEON¿S PLANNED TIBIAL CUT OF NEUTRAL TO THE MECHANICAL AXIS. THE FUNCTIONALITY AND ACCURACY OF THE ROBOTIC SYSTEM WAS VERIFIED ON SITE BY A FIELD SERVICE ENGINEER (FSE) ON APRIL 1, 2022 THROUGH A PREVENTATIVE MAINTENANCE. THE SYSTEM WAS FOUND TO BE IN WORKING ORDER. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR PART NUMBERS 20-8020-100, 208020100. THE SEARCH IDENTIFIED ONE (1) ADDITIONAL COMPLAINT FOR THE SAME SERIAL/LOT NUMBER (¿(B)(6)) WITHIN ONE (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT (FEB 22, 2022) AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. AS THE SEVERITY OF HARM WAS 1, FURTHER EVALUATION IS NOT REQUIRED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROBOTIC INSTRUMENTATION, THE TIBIAL CUT LOOKED TO BE IN VARUS WHEN A NEUTRAL CUT WAS PLANNED. THE SURGEON MEASURED WITH A STANDARD INSTRUMENT AND THIS CONFIRMED HIS VIEW. THE SURGEON RECUT AN EXTRA 2MM WITH STANDARD INSTRUMENTS AND NOTED THAT IT WAS MOSTLY ON THE LATERAL SIDE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROBOTIC INSTRUMENTATION, THE TIBIAL CUT LOOKED TO BE IN VARUS WHEN A NEUTRAL CUT WAS PLANNED. THE SURGEON MEASURED WITH A STANDARD INSTRUMENT AND THIS CONFIRMED HIS VIEW. THE SURGEON RECUT AN EXTRA 2MM WITH STANDARD INSTRUMENTS AND NOTED THAT IT WAS MOSTLY ON THE LATERAL SIDE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642344 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other