BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    MDR report key: 12589967 · Received October 7, 2021

    Report

    Report Number
    3005180920-2021-00794
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862373
    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 21 SEPTEMBER 2021. LOT 2100351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2021. EXPIRATION DATE: 2026-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 21 SEPTEMBER 2021. GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L (K121416) LOT. 2010587 LOT 2010587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2020. EXPIRATION DATE: 2025-10-29. 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 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 2010234 LOT 2010234: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2021. EXPIRATION DATE: 2026-02-15. 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

    2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE TIBIA TENDON HAD COME OFF AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490595 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0023L 2100351 07630030862373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention