BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 7973279 · Received October 17, 2018

    Report

    Report Number
    3005180920-2018-00790
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2018. LOT 170259: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2017. EXPIRATION DATE: 25.05.2022 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. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R REFERENCE 02.12.T3I4R (K121416). LOT 171841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JULY 2017. EXPIRATION DATE: 2022-06-29. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON OCTOBER 17, 2018: ONE YEAR AFTER PRIMARY CEMENTED TKR, A REVISION IS PERFORMED BECAUSE THE SURGEON DECIDED THE ORIGINAL IMPLANT POSITIONS TO BE SUBOPTIMAL AND POTENTIAL CAUSE FOR PATIENT DISSATISFACTION. ACCORDING TO A VERY APPROXIMATED ANALYSIS OF THE POSTOPERATIVE RADIOGRAPHS (APPROXIMATION DUE TO LOW QUALITY OF THE IMAGES), THE COMPONENTS SEEM TO HAVE BEEN PLACED SUBSTANTIALLY AS PLANNED, EXCEPT POSTERIOR TIBIAL SLOPE (LOWER THAN PLANNED) AND FEMORAL FLEXUM (HIGHER THAN PLANNED). WE CANNOT DETERMINE THE INFLUENCE THAT THESE VARIATIONS MAY HAVE HAD ON THE FINAL OUTCOME NOR THE REASONS THAT LED THE SURGEON TO MAKE THESE INTRAOPERATIVE CHANGES, BUT WE FIND NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. INVESTIGATION PERFORMED BY PATIENT MATCH DEPARTMENT ON SEPTEMBER 26, 2018: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE FOR FEMUR AND TIBIAL TRAY MAL POSITIONING DURING PRIMARY. ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815135 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 170259 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention