BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 19665066 · Received July 3, 2024

    Report

    Report Number
    3005180920-2024-00486
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 JUNE 2024. LOT 174581: (B)(4) MANUFACTURED AND RELEASED ON 23-NOV-2017. EXPIRATION DATE: 2022-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRELIMINARY ANALYSIS PERFORMED BY R&D PROJECT MANAGER FROM THE ANALYSIS ON PICTURES OF THE EXPLANTED COMPONENTS, NO RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF TIBIAL BASEPLATE. SIGNS OF WEAR CAN BE NOTED ON THE MEDIAL ARTICULAR SURFACE OF THE TIBIAL INSERT. NO ANOMALIES CAN BE NOTED ON THE FEMORAL COMPONENT. DENTS AND SCRATCHES CAN BE NOTED ON THE COMPONENTS MOST LIKELY CAUSED DURING THE ATTEMPT TO REMOVE THE IMPLANTS. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). ABSENCE OF CEMENT, IS NOT AN EVIDENCE OF A FAULTY DEVICE. SIGNS OF WEAR COULD HAVE BEEN CAUSED FOR RELATIVE TIBIO-FEMORAL MALPOSITIONING WHEN THE TIBIA BECAME LOOSE. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Additional Manufacturer Narrative · 0

    FOLLOW UP IN ORDER TO CORRECT THE PRODUCT CODE (SECTION D2B): IT WAS REPORTED JWK, BUT THE CORRECT CODE IS JWH.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER FROM VISUAL INVESTIGATION BASED ON RECEIVED EXPLANTED COMPONENTS, NO RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF TIBIAL BASEPLATE. SIGNS OF WEAR CAN BE NOTED ON THE MEDIAL ARTICULAR SURFACE OF THE TIBIAL INSERT. THE MEDIAL EDGE OF THE ARTICULAR SURFACE LOOKS PRESSED LIKE IF THE FEMUR WAS ARTICULATING ON THAT. NO ANOMALIES CAN BE NOTED ON THE FEMORAL COMPONENT. DENTS AND SCRATCHES CAN BE NOTED ON THE COMPONENTS MOST LIKELY CAUSED DURING THE ATTEMPT TO REMOVE THE IMPLANTS. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). ABSENCE OF CEMENT, IS NOT AN EVIDENCE OF A FAULTY DEVICE. SIGNS OF WEAR COULD HAVE BEEN CAUSED FOR RELATIVE TIBIO-FEMORAL MALPOSITIONING WHEN THE TIBIA BECAME LOOSE. THERE IS NO EVIDENCE TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 21 AUGUST 2024 ON GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L (K121416) LOT. 162169 LOT 162169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2017. EXPIRATION DATE: 2022-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFORMATION REPORTED IN THIS SECOND FOLLOW UP: PIECES RETURNED ON 19 AUGUST 2024. VISUAL INSPECTION OF THE PIECES BATCH OF THE LINER.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 6 YEARS 1 MONTH AFTER THE PRIMARY DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT THAT CAUSED THE WEAR AND TEAR OF THE LINER ON THE MEDIAL SIDE. THE SURGEON REVISED SUCCESSFULLY TIBIAL COMPONENT, INSERT AND FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139800 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 174581 07630030819926
    579642 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 174581 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention