BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L

    MDR report key: 16023348 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00943
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 28, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825873
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 1 DECEMBER 2022. LOT 2005347: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2020. EXPIRATION DATE: 2025-SEP-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 1 DECEMBER 2022. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L ((B)(4)), LOT: 2005043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-SEP-27. 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

    THE PATIENT CAME IN REPORTING PAIN. THE XRAYS INDICATED THAT THE IMPLANTS WERE LOOSE. AT ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, DURING REVISION SURGERY, THE SURGEON NOTED FEMUR AND TIBIA WERE ABLE TO BE REMOVED WITH MILD TO MODERATE DISTRACTION FORCE. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. REVISION SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153255 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0006L 2005347 07630030825873

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention