BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 8288676 · Received January 30, 2019

    Report

    Report Number
    3005180920-2019-00013
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    December 31, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JANUARY 2019. LOT 175636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2017 . EXPIRATION DATE: 06.11.2022 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 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L REFERENCE 02.12.0024L (K140826). LOT: 173652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-29. 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. GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L REFERENCE 02.12.0413FL (K140826). LOT 173652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-29. 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. PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE EXPLANTED COMPONENTS PERFORMED BY R&D PRODUCT MANAGER: REVISION SURGERY FOR INFECTION AFTER 1 YEAR FROM PRIMARY IMPLANTATION AND 3 MONTHS AFTER A FIRST REVISION SURGERY FOR A POLY SWAP DUE TO PAIN. NO TRACES OF RESIDUAL CEMENT CAN BE SEEN ON THE TIBIAL TRAY. SOME RESIDUAL BONE CAN BE SEEN ON THE INTERNAL DISTAL MEDIAL SURFACE OF THE FEMORAL COMPONENT. THERE IS NO EVIDENCE THAT POOR INTER-DIGITATION BETWEEN CEMENT AND IMPLANT IS AN INFECTION PROMOTING FACTOR.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 8 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN. A POLY SWAP WAS PERFORMED (SEE MDR 2018-00786). NOW, 3 MONTH AND A HALF AFTER THE FIRST REVISION SURGERY, THE PATIENT CAME IN DUE TO INFECTION. THE SURGEON REVISED ALL THE IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83200 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 175636 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention