BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 13451267 · Received February 4, 2022

    Report

    Report Number
    0009617840-2022-00008
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 11, 2022
    Report Date
    July 7, 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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SAME/SIMILAR TO ROSA UNIT 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). SAME/SIMILAR TO PRODUCT 510(K): K182964. G2: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN AUSTRALIA. THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, G1-2, G3, G6, H2, H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO 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
    947331 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other