BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20448872 · Received October 15, 2024

    Report

    Report Number
    3005180920-2024-00813
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825880
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2024: 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R LOT 140304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2014. EXPIRATION DATE: 2019-01-31. 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 COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2024: REF. 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 133916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2014. EXPIRATION DATE: 2018-08-31. 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. BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2024: REF. 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 140176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2014. EXPIRATION DATE: 2019-02-28. 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. BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2024: REF. 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R (K121416) LOT. 140360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2014. EXPIRATION DATE: 2019-01-31. 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

    FIRST STAGE KNEE REVISION FOR INFECTION AT ABOUT 10 YEARS AND 3 MONTHS POST PRIMARY. ALL IMPLANTS WERE REMOVED AND WASHOUT WAS PERFORMED. A COMPETITOR SPACER WAS IMPLANTED AS THE JOINT WAS INFECTED. AFTER A CHECK OF THE AGENT WITH THE HOSPITAL, NO FURTHER INFORMATION WILL BE AVAILABLE REGARDING THE 2ND STAGE REVISION OR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360178 GMK SPHERE TOTAL KNEE SYSTEM KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0006R 140304 07630030825880

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Female Required Intervention