BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 13417029 · Received February 1, 2022

    Report

    Report Number
    0009617840-2022-00009
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 12, 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
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET - (B)(4). THIS PRODUCT IS SIMILAR TO PMA/510(K) : 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 FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378431 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other