BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA RECON PLATFORM 220V

    MDR report key: 14022594 · Received April 6, 2022

    Report

    Report Number
    0009617840-2022-00017
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 11, 2022
    Report Date
    July 28, 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

    THIS REPORTED EVENT WAS CONFIRMED. INVESTIGATION LOG FILES WERE PROVIDED TO THE PRODUCT SURVEILLANCE TEAM FOR FURTHER EVALUATION AND REVIEWED BY A SUBJECT MATTER EXPERT. THE REPORTED ISSUE NOT BEING CONFIRMED TO BE PRIOR TO ITS FIRST USE SUGGEST IT IS UNLIKELY TO BE THE RESULT OF A MANUFACTURING, INSTALLATION, OR MAINTENANCE/SERVICING DEFICIENCY. AS SUCH, A MANUFACTURING DHR REVIEW WAS NOT PERFORMED. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). COUNTRY OF ORIGIN SINGAPORE, SAME OR 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

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TKA AN OVER-RESECTION OF 5-6MM OCCURRED ON THE TIBIA. DUE TO THIS OVER-RESECTION, A 14MM ARTICULATING SURFACE WAS USED INSTEAD OF A 10MM SURFACE. OTHER THAN THAT DEVIATION IN ARTICULAR SURFACE, THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581458 ROSA RECON PLATFORM 220V N/A OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other