BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R

    MDR report key: 9786033 · Received March 4, 2020

    Report

    Report Number
    3005180920-2020-00117
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14-FEB-2020: LOT 183058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUL-2018. EXPIRATION DATE: 06-18-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ANOTHER IMPLANTS INVOLVED: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 1810474. BATCH REVIEWS PERFORMED ON 14-FEB-2020: LOT 1810474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ANOTHER IMPLANTS INVOLVED: GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R (K140826) LOT. 183461. BATCH REVIEWS PERFORMED ON 14-FEB-2020: LOT 183461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2018. EXPIRATION DATE: 20.08.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ANOTHER IMPLANTS INVOLVED: GMK-SPHERE 02.07.F11066 PRIMARY EXTENSION STEM Ø11MM / L 65 MM (K090988) LOT. 1900598. BATCH REVIEWS PERFORMED ON 14-FEB-2020: LOT 1900598: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2019. EXPIRATION DATE: 01.05.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ANOTHER IMPLANTS INVOLVED:GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 1903586. BATCH REVIEWS PERFORMED ON 14-FEB-2020: LOT 1903586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 16.06.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 3 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248479 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R KNEE IMPLANT: TIBIAL INSERT FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0411FR 183058 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention