BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 17886293 · Received October 6, 2023

    Report

    Report Number
    3005180920-2023-00780
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-OCT-2023 LOT 178716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2018. EXPIRATION DATE: 2023-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION "PERFORMED" BY MEDICAL AFFAIRS DIRECTOR: 4 YEARS AFTER PRIMARY CEMENTED TKA, A REVISION IS PERFORMED. NO INFORMATION WAS SUPPLIED. FROM THE PRE-REVISION XRAYS, A TERMINAL DAMAGE TO THE COLLATERAL LIGAMENTS SEEM TO HAVE TAKEN PLACE, POSSIBLY BECAUSE OF TRAUMA, AND OF COURSE A CONSTRAINED DEVICE WAS THEN CALLED FOR. WITHOUT ADDITIONAL INFORMATION, NO FURTHER COMMENT CAN BE OFFERED, BUT WE SEE NO CLUE TOWARDS A DEFECT IN THE IMPLANTED DEVICE OR ITS PERFORMANCES. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT 1901315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 2024-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 1901601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2019. EXPIRATION DATE: 2024-05-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INSTABILITY. ALL THE COMPONENTS HAVE BEEN REVISED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202352 GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 178716 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention