BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY CR

    MDR report key: 25116584 · Received May 7, 2026

    Report

    Report Number
    3014833750-2026-00104
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    December 23, 2025
    Report Date
    May 7, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    MBH
    UDI-DI
    M572TCR1011112011
    PMA / PMN Number
    K243768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TIBIAL IMPLANT OF A TOTAL KNEE SYSTEM WAS IMPLANTED IN SUCH A WAY THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND A SCREW IN THE PATELLAR TENDON, SUGGESTING THAT THERE WAS EXCESSIVE SLOPE IN THE WAY THE TIBIAL IMPLANT WAS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND IT IS NOT PRESENTLY CLEAR WHICH MODEL OR VERSION OF THE DEVICE IS IN SCOPE OF THIS ADVERSE EVENT. ADDITIONAL INFORMATION THAT BECOMES AVAILABLE WILL BE SUBMITTED VIA FOLLOW-UP AS IT BECOMES AVAILABLE. IMPROPER IMPLANT PLACEMENT IS A WELL-KNOWN RISK OF TOTAL KNEE REPLACEMENT AND COULD BE CAUSED BY IMPROPER JIG DESIGN OR INTROPERATIVE ERROR BY THE USER. DISCUSSION WITH THE USER INDICATES IMPROPER CUT LOCATION DURING JIG USE MAY HAVE BEEN CAUSED BY MISUSE OR IMPROPER INSTRUMENT SEATING DURING SURGERY. ANALYSIS OF PRODUCTION RECORDS AND DESIGN RECORDS REVEALS NO ABNORMALITY THAT COULD HAVE CONTRIBUTED TO THE SUBJECT ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TIBIAL IMPLANT OF A TOTAL KNEE SYSTEM WAS IMPLANTED IN SUCH A WAY THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND A SCREW IN THE PATELLAR TENDON, SUGGESTING THAT THERE WAS EXCESSIVE SLOPE IN THE WAY THE TIBIAL IMPLANT WAS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND IT IS NOT PRESENTLY CLEAR WHICH MODEL OR VERSION OF THE DEVICE IS IN SCOPE OF THIS ADVERSE EVENT. ADDITIONAL INFORMATION THAT BECOMES AVAILABLE WILL BE SUBMITTED VIA FOLLOW-UP AS IT BECOMES AVAILABLE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIBIAL IMPLANT OF A TOTAL KNEE SYSTEM WAS IMPLANTED IN SUCH A WAY THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND A SCREW IN THE PATELLAR TENDON, SUGGESTING THAT THERE WAS EXCESSIVE SLOPE IN THE WAY THE TIBIAL IMPLANT WAS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIBIAL IMPLANT OF A TOTAL KNEE SYSTEM WAS IMPLANTED IN SUCH A WAY THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND A SCREW IN THE PATELLAR TENDON, SUGGESTING THAT THERE WAS EXCESSIVE SLOPE IN THE WAY THE TIBIAL IMPLANT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456707 ITOTAL IDENTITY CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT MBH RESTOR3D, INC. ED-08081 M572TCR1011112011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention