BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA PERSONA TKA CUT GUIDE A

    MDR report key: 12624672 · Received October 13, 2021

    Report

    Report Number
    0009617840-2021-00022
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 13, 2021
    Report Date
    March 31, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024505179
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT : (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. SUMMARY: TECHNICAL REVIEW AND PHYSICAL EVALUATION: SUBJECT MATTER EXPERT LOG ANALYSIS OF THE REPORTED EVENT, CONFIRMED ¿THE FEMUR RESECTION AND CUT BLOCK. BUT THE LOG DO NOT CONFIRM THE TIBIA RESECTION. THE FEMUR OVER-RESECTION WAS CONFIRMED BY THE VALIDATION DATA BOTH ON THE MEDIAL AND LATERAL RESECTION. THE OVER-RESECTION WAS ALSO CONFIRMED WITH A CALIPER MEASUREMENT. THE TIBIA RESECTION. THE LOGS DO NOT REVEAL ANY REGISTERED VALIDATION DATA FOR THE TIBIA CUT. THE LIVE CUT VALUES AND THE VALIDATION TOOL ARE VISIBLE TO THE CAMERA TOWARD THE END OF THE RESECTION FLOW. IT IS POSSIBLE THAT THE USER SAW THE VALIDATED VALUE AND SIMPLY DID NOT ACCEPT THEM. UNFORTUNATELY, THIS MEANS THE VALUE SEEN ON SCREEN WAS NOT RECORDED IN THE LOGS. THE CUT BLOCK WOULD NOT PASSING CHECKPOINT VALIDATION: TECHNICAL AND PHYSICAL INSPECTION OF THE CUT BLOCK SHOWED CRUSHED THREADS AT ONE OF THE TWO THUMBS SCREWS ALONG WITH EXCESSIVE WEAR AT THE CUT SLOTS AREAS. IT WAS DEEMED NON-CONFORM BY THE MANUFACTURING TEAM. THIS COULD HAVE AFFECTED THE MOUNTING OF THE CUT BLOCK AND RESULTED IN THE CHECKPOINT FAILURES. OTHERS FACTORS CONTRIBUTED TO THE REPORTED EVENT: FEMUR AND TIBIA 3MM OVER-RESECTION: CHANGE OF ORIENTATION OF THE CAMERA, OR CHANGE OF ORIENTATION OF THE BASE TRACKER. THE SECOND REGISTRATION MIGHT HAVE BEEN AFFECTED BY NON-OPTIMAL MOUNTING OF THE ARM REFERENCE, AN INSTABILITY OF THE ROBOT OR CAMERA, PREVENTIVE MAINTENANCE, SOFTWARE AND HARDWARE UPGRADE WAS PERFORMED BY A FIELD SERVICE TECHNICIAN ON (B)(6) 2021, ROBOTIC SYSTEM WAS TESTED AS PER PROCEDURE, ALL TESTS PASSED SUCCESSFULLY. NO DEVICE OR SOFTWARE ISSUES WERE FOUND. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE: A PRECISE ROOT CAUSE FOR REPORTED RESECTIONS DISCREPANCIES CANNOT BE DETERMINED. PROBABLE CAUSE IS ROBOT BASE TRACKER MOVEMENT. OTHER POTENTIAL FACTORS INCLUDE: DAMAGED OR WORN CUT BLOCK; INSTABILITY OF THE ROBOT CAMERA; AN UNUSUAL LANDMARKING SECTION AND A MOVEMENT OF THE BONE TRACKER; ERRONEOUS LANDMARKS ON A GENERIC BONE MODEL; POOR SIX-POINT REGISTRATION; DEFECTIVE VALIDATION TOOL/LOOSE VALIDATION TOOL TRACKER/VALIDATION TOOL NOT MOUNTED CORRECTLY. A PRECISE ROOT CAUSE FOR REPORTED CHECKPOINT FAILURE FOR CUT GUIDE CANNOT BE DETERMINED. ALTHOUGH THE CUT GUIDE WAS FOUND TO BE DAMAGED THROUGH USE BY ZIMMER STAFF, A PROBABLE ROOT CAUSE IS A MOVEMENT OF ROBOT BASE TRACKER. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA AND FEMUR RESECTIONS WERE 3MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES DUE TO A DEFECTIVE CUTTING BLOCK. THE PROCEDURE WAS COMPLETED USING A LARGER POLY WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA AND FEMUR RESECTIONS WERE 3MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521329 ROSA PERSONA TKA CUT GUIDE A ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A J190690 00889024505179

    Patients

    Seq Age Sex Outcome Treatment
    1 Female