BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 13417756 · Received February 1, 2022

    Report

    Report Number
    0009617840-2022-00007
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 1, 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386343 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other