BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R

    MDR report key: 10453190 · Received August 26, 2020

    Report

    Report Number
    3005180920-2020-00551
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825880
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 AUGUST 2020: LOT 123713: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2013. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 124572. BATCH REVIEW PERFORMED ON 07 AUGUST 2020: LOT 124572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-DEC-2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIA AND FEMUR. THE SURGEON OBSERVED THAT THERE WAS NO CEMENT PRESENT ON THE IMPLANTS. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT 7 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920373 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0006R 123713 07630030825880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention