BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12432335 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00718
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    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 16-AUG-2021: LOT 1905098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-NOV-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R (K140826) LOT. 1905089 LOT 1905089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-OCT-2019. EXPIRATION DATE: 2024-SEPT-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0413CRR TIBIAL INSERT FIXED SPHERE CR SIZE 4/13 MM R (K181635) LOT. 185624 LOT 185624: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2018. EXPIRATION DATE: 2023-SEPT-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330274 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R KNEE TIBIAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 1905098 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention