BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 9681177 · Received February 7, 2020

    Report

    Report Number
    3005180920-2020-00027
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20.01.2020: LOT 170445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2017. EXPIRATION DATE: 2022-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PATIENT MATCH PLANNING REVIEW: HERE BELOW YOU CAN FIND THE DETAILED ANALYSIS OF THE PROCESS: IMAGES QC: THE DATASET FULLY RESPECTS THE PROTOCOL. THE IMAGES WERE NOT EXPIRED AT THE TIME OF THE SURGERY (SEE THE SCREEN SHOT BELOW OF THE REPORT OF THE QC). RECONSTRUCTION: THE RECONSTRUCTED PROFILE FOLLOWS PRECISELY THE CONTOUR OF THE BONE, AS SHOWN IN THE SCREEN SHOTS BELOW (LATERAL VIEWS MOVING LATERALLY; PROFILE OF THE RECONSTRUCTED BONES IN YELLOW). PLANNING LANDMARKS: ALL THE LANDMARKS WERE TAKEN ACCORDINGLY TO THE PROCESS, AS SHOWN IN THE SCREEN SHOTS BELOW. PRE-OP INFORMATION: AS PER THE OTHER CASES, THE ONLY INFORMATION AVAILABLE TO THE MY KNEE TEAM WAS ABOUT THE BONES. NO PRE-OP INFORMATION WAS AVAILABLE REGARDING: THE STATUS OF THE LIGAMENTS: THIS INFORMATION, AS FOR ALL THE CASES, IS AVAILABLE JUST TO THE SURGEON. THE THICKNESS OF THE CARTILAGE: THIS INFORMATION IS NOT AVAILABLE, SINCE THIS CASE IS CT- BASED. PLANNING PROPOSAL: IN THE PLANNING PROPOSAL, ALL THE CHOSEN PARAMETERS ARE WITHIN THE RANGE OF PREFERENCES SET BY THE SURGEON ON THE WEBSITE. PLANNING REVISION: AS SHOWN IN THE ATTACHED EMAIL THE SALES REPRESENTATIVE ASKED FOR A REVISION OF THE PLANNING. WE UPLOADED A REV.1 MADE ACCORDINGLY TO HIS INDICATIONS. PLANNING VALIDATION: AS SHOWN IN THE SCREEN SHOT BELOW, THE REV.1 WENT INTO AUTOMATIC VALIDATION WITHOUT ANY FURTHER CHANGE. PLANNING CHOICE OF THE SIZE: THE SCREEN SHOTS BELOW SHOW THE COVERAGE OFFERED BY THE GMK SPHERE COMPONENT OF THE VALIDATED REV. 1: SIZE 5+ FOR THE FEMUR AND SIZE 5 FOR THE TIBIA. THE SURGEON IMPLANTED A SIZE 5 ON THE FEMUR; NO INFORMATION IS AVAILABLE REGARDING THE IMPLANTED SIZE ON THE TIBIA. FEMORAL CUTTING BLOCK: ALL THE PADS ARE IN CONTACT WITH PARTS THAT CANNOT GET DETACHED. FROM THE FIRST IMAGE ON THE LEFT WE HAVE TWO AXIAL VIEWS MOVING DISTALLY, TWO FRONTAL VIEWS MOVING POSTERIORLY AND A 3D VIEW (PROFILE OF THE RECONSTRUCTED BONE IN YELLOW AND PROFILE OF THE CUTTING BLOCK IN GREEN). TIBIAL CUTTING BLOCK: ALL THE PADS ARE IN CONTACT WITH PARTS THAT CANNOT GET DETACHED. FROM THE FIRST IMAGE ON THE LEFT WE HAVE SOME AXIAL VIEWS MOVING DISTALLY (PROFILE OF THE RECONSTRUCTED BONE IN YELLOW AND PROFILE OF THE CUTTING BLOCK IN GREEN) AND A 3D VIEW. EXTRA-ANALYSIS: NO EXTRA-ANALYSIS IS POSSIBLE SINCE WE RECEIVED NO X-RAYS. CONCLUSIONS: OUR ANALYSIS OF THE MY KNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 2 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO MALROTATED TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT (NEW INSERT 13MM). PREVIOUSLY THIS PATIENT HAD PATELLA RESURFACING AND INSERT SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147623 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204R 170445 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention