BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA KNEE PLATFORM US PL B

    MDR report key: 14174615 · Received April 21, 2022

    Report

    Report Number
    0009617840-2022-00019
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    October 4, 2021
    Report Date
    April 26, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). PLEASE NOTE THAT THIS INCIDENT WAS PREVIOUSLY DOCUMENTED UNDER MFR: 0001822565 - 2021 - 03067. THIS INCIDENT IS BEING RESUBMITTED TO MORE ACCURATELY DOCUMENT THE REPORTED EVENT. ALL NECESSARY INFORMATION NEEDED FOR A INVESTIGATION HAS BEEN PROVIDED, THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT : (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SUMMARY: TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE LOG FILE ANALYSIS CONFIRMS THE REPORTED ISSUE. THE VALIDATION VALUES WAS MEASURED ONCE AFTER THE CUT STEP, AND INDICATED AN OVER RESECTION ON THE MEDIAL SIDE AND ON THE LATERAL SIDE. THERE WAS A 55 SECOND INTERRUPTION OF LIVE VALUES WHERE THE TRACKER COULD NOT BE SEEN. WHEN THE LIVE VALUES ARE VISIBLE AGAIN, THE MEDIAL SIDE IS RESECTED 2.1MM MORE THAN PLANNED AND LATERAL SIDE 2.3MM MORE. PREVENTIVE MAINTENANCE AND SOFTWARE UPDATE WAS PERFORMED BY FIELD SERVICE TECHNICIAN ON JAN 24, 2022, SYSTEM PASSED ALL TESTS SUCCESSFULLY, AND NO SOFTWARE APPLICATION OR DEVICE MALFUNCTION WERE NOTED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED DHR REVIEW: REVIEW OF THE DHR IDENTIFIED NO DEVIATION AND/OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. COMPLAINT HISTORY REVIEW A COMPLAINT HISTORY REVIEW WAS CONDUCTED. THE SEARCH IDENTIFIED NO ADDITIONAL RELEVANT COMPLAINTS REPORTED FOR THIS DEVICE. THE SEARCH IDENTIFIED ELEVEN (11) ADDITIONAL COMPLAINTS REPORTED FOR THE PART # CONCERNED WITHIN ONE (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT (OCT 14, 2021) AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS PER QI09-03. 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 A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) 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 ROBTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) 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
    605626 ROSA KNEE PLATFORM US PL B ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other