BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM LEFT

    MDR report key: 6240351 · Received January 11, 2017

    Report

    Report Number
    3005180920-2016-00723
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 11, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 13 DECEMBER 2016 AND INCLUDES: THE SURGERY WENT VERY WELL. GMK-SPHERE INLAY 11 MM WAS EXPLANTED AND A 17 MM INLAY WAS IMPLANTED. AFTER THIS, THE JOINT WAS STABLE. THE REASON OF THE REVISION WAS CONFIRMED AS POSTERIOR LUXATION OF THE TIBIA. ON 22 DECEMBER 2016 THE PATIENT MATCH DEPARTMENT PROVIDED A PLANNING REVIEW, REPORTING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. NO ERRORS HAVE BEEN FOUND IN ANY STEP. THE SURGEON DECIDED INTRA-OPERATIVELY TO IMPLANT A SMALLER SIZE FOR BOTH THE FEMUR AND THE TIBIA. ON 04 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INSERT REVISION IN TKA 3 MONTHS AFTER PRIMARY SURGERY DUE TO JOINT INSTABILITY. THE INSERT WAS EXCHANGED TO A THICKER ONE. THE DEVELOPMENTAL INSTABILITY IS A RATHER COMMONLY DESCRIBED POSSIBLE COMPLICATION FOLLOWING TKA, BECAUSE SOFT TISSUE MAY STRETCH AND PROVIDE INSUFFICIENT STABILITY. IT IS THEREFORE COMMON PRACTICE TO RESORT A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THIS IS NOT A PROBLEM DUE TO ANY IMPLANT DEFECT OR MALFUNCTION. BATCH REVIEW PERFORMED ON 09 JANUARY 2017. LOT 152926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. IN FLEXION THE TIBIA LUXATES SOMETIMES IN POSTERIOR DIRECTION. A REVISION SURGERY HAS BEEN PLANNED. AFTER SURGERY, POSTERIOR LUXATION OF THE TIBIA WAS CONFIRMED AS REASON OF THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23943 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 152926

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention