BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA KNEE PLATFORM US PL B

    MDR report key: 12984829 · Received December 13, 2021

    Report

    Report Number
    0001822565-2021-03500
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    June 25, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS INCIDENT WAS DEEMED REPORTABLE FOR DEVICE MALFUNCTION AFTER THE INVESTIGATION RESULTS WERE MADE AVAILABLE TO COMPLAINT HANDLER ON 16-NOV-2021. ROSA CAMERA ACCURACY VERIFIED FROM THE INVESTIGATION LOG FILES. ALL SETUP STEPS FOR ROSA SURGERY OCCURRED WITHOUT ISSUE. ONSITE REPRESENTATIVE REPORTED REPORTED BY EMAIL THAT THE CUT GUIDE WAS NOT POSITIONED IN THE SAME POSITION RELATIVE TO THE BONE AS IN THE FIRST CUT ON THE TIBIAL RESECTION. THIS INFORMATION INDICATED A MOVEMENT OF THE BONE NAVITRACKER RELATIVE TO THE CUT GUIDE. THIS SUGGEST A RETRACTOR WAS PUT IN PLACE AFTER PINNING CUT GUIDE INSTEAD OF BEFORE AS RECOMMENDED BY SURGICAL TECHNIQUE. REVIEW OF THE DHR FOR P/N 20-8020-100-01, S/N (B)(4) (ROSA RECON PLATFORM US PL B) IDENTIFIED NO DEVIATION AND/OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 ROSA CUT VALIDATIONS WERE OFF FROM PLANNED TIBIAL VALUES BY 4MM ON MEDIAL AND LATERAL SIDES. UPON COMPLETION OF THE INVESTIGATION INTO THIS INCIDENT AND REASSESSMENT OF THE COMPLAINT IT WAS DETERMINED THAT OVER RESECTION OF 4MM HAD OCCURRED ON TIBIA. THE PROCEDURE WAS COMPLETED 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
    1885175 ROSA KNEE PLATFORM US PL B ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown