BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GPS TKA PRO SOFTWARE

    MDR report key: 11970985 · Received June 9, 2021

    Report

    Report Number
    1038671-2021-00285
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 29, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    OJP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: TECHNICAL LOG REVIEWED. THERE WAS A DISCREPANCY BETWEEN THE PLANNED AND THE CHECKED NAVIGATED VALUES MOST LIKELY BECAUSE THE G TRACKER WAS NOT PROPERLY ENGAGED ON A REPRODUCIBLE FIXATION DURING THE FIRST DISTAL CUT GUIDANCE STEP. BECAUSE THE G TRACKER WAS NOT CORRECTLY CLIPPED, THIS IS CONSIDERED AS A BAD USE OF THE SYSTEM BY THE USER.

    Description of Event or Problem · 0

    THERE WAS LESS THAN A 5 MINUTE SURGICAL DELAY WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COMPLEX CASE, (AMPUTATED RIGHT LEG, LATERAL PLATE FROM PROXIMAL FEMUR TO DISTAL FEMUR WITH SEQUELAE OF MALUNION LEFT FEMUR), THERE WERE 2 MINOR THINGS THAT NEEDED TO BE LOOKED AT. DISTAL FEMORAL CUT: WHEN THE DISTAL FEMORAL CUT WAS CHECKED, THERE WAS A CLEAR DISCREPANCY BETWEEN THE PLAN (M: 11MM, L: 12MM) AND THE CHECK (M:14MM, L:7MM). THE REP ASKED THE SURGEON TO GO BACK TO THE DISTAL CUT GUIDANCE AND IT CONFIRMED THE CHECKED NUMBERS. ALSO, THE SURGEON WAS ASKED TO MEASURE THE ACTUAL CUTS AND IT CONFIRMED THE CHECKED NUMBERS. THEREFORE THE REP ASSUMED THAT THE G TRACKER WAS NOT PROPERLY ENGAGED DURING THE INITIAL DISTAL CUT GUIDANCE. ULTIMATELY, IT HAS BEEN DECIDED TO RE-PERFORM THE CUT GUIDANCE AND PERFORMED A SUBSEQUENT CUT WHICH CORRECTED THE ISSUE (EXCEPT THE MEDIAL ASPECT OF THE RESECTION WHICH HAS BEEN OVER RESECTED DURING THE FIRST CUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867423 GPS TKA PRO SOFTWARE ORTHOPEDIC COMPUTER CONTROLLED SURGICAL SYSTEM OJP EXACTECH, INC. GPS TKA PRO SOFTWARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention