BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGAGE SURGICAL PARTIAL KNEE SYSTEM

    MDR report key: 11791749 · Received May 7, 2021

    Report

    Report Number
    3016249968-2021-00003
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 7, 2021
    Manufacturer
    ENGAGE UNI LLC (DBA ENGAGE SURGICAL)
    Product Code
    NJD
    PMA / PMN Number
    K190439
    Removal / Correction Number
    RES 92286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION UPDATE: AS CORRECTION ACTION A VOLUNTARY MARKET REMOVAL WILL BE PERFORMED FOR THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM DUE RECENT COMPLAINT DATA THAT INDICATES THAT THE REVISION RATE MAY BE TRENDING HIGHER THAN CORRESPONDING SIMILAR DEVICES IN GLOBAL JOINT REPLACEMENT REGISTRIES. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION MAY BE INDICATED.

    Additional Manufacturer Narrative · 1

    THE SURGEON USED THE EXACTECH GPS NAVIGATION SYSTEM TO PREPARE THE TIBIA INSTEAD OF USING THE ENGAGE SURGICAL INSTRUMENTATION. THE SURGEON BELIEVES THAT A PIN HOLE BELOW THE TIBIAL TRAY MAY HAVE CAUSED THE ISSUE. THIS PIN HOLE LOCATION IS FROM THE EXACTECH GPS NAVIGATION SYSTEM, WHICH HAS NOT BEEN VALIDATED FOR USE WITH THE ENGAGE SYSTEM. THE ENGAGE SURGICAL IMPLANTS WERE NOT RETURNED FOR EVALUATION, SINCE THEY REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING MINOR KNEE PAIN DURING THE EIGHT WEEKS POST-OP FOLLOW-UP APPOINTMENT. THE SURGEON REVIEWED THE X-RAYS AND DETERMINED THAT THE PATIENT HAD A PROBABLE SUBACUTE FRACTURE ON THE RIGHT SIDE. AT 12 WEEKS, THE PATIENT IS DOING FINE, WITH NO PAIN, AND IS FULLY AMBULATORY; NO FURTHER TREATMENT IS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691179 ENGAGE SURGICAL PARTIAL KNEE SYSTEM UNICOMPARTMENTAL/UNICONDYLAR UNCEMENTED KNEE PROSTHESIS NJD ENGAGE UNI LLC (DBA ENGAGE SURGICAL) 1-10012-550 100061

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other EXACTECH GPS NAVIGATION SYSTEM