BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 20154931 · Received September 6, 2024

    Report

    Report Number
    3005180920-2024-00685
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-AUG-2024 LOT 2007316: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2020. EXPIRATION DATE: 2025-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INFO INVOLVED, BATCH REVIEW PERFORMED ON 09-AUG-2024 GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R (K140826) LOT 2003249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2020. EXPIRATION DATE: 2025-JUL-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED DUE TO FEMORAL AND TIBIAL TRAY MOBILIZATION. ALL IMPLANTS REVISED SUCCESSFULLY TO COMPETITOR'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268343 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2007316 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention