BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    MDR report key: 17388489 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00567
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 JULY 2023: LOT 2112437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 142 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON (B)(4) 2023. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT 2109864: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2021. EXPIRATION DATE: 2026-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 97 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT 2110987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: 2026-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED 1,5 YEAR AFTER THE FIRST IMPLANT OF A GMK SPHERE WITHOUT RESURFACING PATELLA, USING MYKNEE INSTRUMENTS. THE PATIENT COMPLAINED OF ANTERIOR KNEE PAIN AND JOINT STIFFNESS (WITH MAXIMUM FLEXION AT 20°). FROM THE AVAILABLE X RAY IMAGES, WE CAN ASSESS A MILD SUBSIDENCE OF THE TIBIAL TRAY MEDIALLY AND ANTERIORLY AND NO LOOSENING. ALSO, WE CAN OBSERVE A PATELLA BAJA THAT MAY BE ACCOUNTED AMONG THE CAUSES OF ANTERIOR KNEE PAIN AND RESTRICTED RANGE OF MOTION. WE HAVE NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE. THE REVISION SURGERY PROVIDED THE IMPLANT OF A GMK REVISION WITH RESURFACING PATELLA.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR 5 MONTHS AFTER THE PRIMARY DUE TO SIGNIFICANT KNEE STIFFNESS WITH MAXIMUM FLEXION AT 20 DEGREES. ANTERIOR PAIN DESCRIBED BY THE PATIENT. NO IMPLANT LOOSENING. NO INFECTIONS. THE SURGEON REVISED SUCCESSFULLY GMK-SPHERE SYSTEM TO GMK-REVISION AND RESURFACED THE NATURAL PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946575 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2112437 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention