BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA KNEE PLATFORM GB PL G

    MDR report key: 13252855 · Received January 13, 2022

    Report

    Report Number
    0009617840-2022-00004
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    December 13, 2021
    Report Date
    July 15, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SAME/SIMILAR TO K182964 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

    REVIEW OF THE DEVICE HISTORY REPORT IDENTIFIED NO DEVIATION OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. PRECISE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 PROCEDURE WHILE USING ROSA INSTRUMENTATION, THERE WAS AN OVER RESECTION FROM PLANNED TIBIAL CUT OF 6MM. A 16MM INLAY WAS USED AND THE KNEE WAS STABLE AND WELL BALANCED. AS OF THIS REPORT SUBMISSION THERE HAS BEEN NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999559 ROSA KNEE PLATFORM GB PL G ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other