BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 13205636 · Received January 10, 2022

    Report

    Report Number
    0009617840-2021-00027
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 17, 2021
    Report Date
    June 29, 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

    ZIMMER BIOMET (B)(4). 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION THE TIBIA WAS OVER-RESECTED BY 2MM MEDIALLY AND 3.5MM LATERALLY. DUE TO THIS DEVIATION FROM THE SURGICAL PLAN, A 16MM TIBIAL IMPLANT WAS NEEDED WHEN A 10MM IMPLANT WAS PLANNED. PATIENT HAD NO IMPACT AND WAS NOT AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION THE TIBIA WAS OVER-RESECTED BY 2MM MEDIALLY AND 3.5MM LATERALLY. DUE TO THIS DEVIATION FROM THE SURGICAL PLAN, A 16MM TIBIAL IMPLANT WAS NEEDED WHEN A 10MM IMPLANT WAS PLANNED. PATIENT HAD NO IMPACT AND WAS NOT AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580955 ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other