BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 14346312 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00352
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 APRIL 2022: LOT 173641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2017. EXPIRATION DATE: 2022-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 22 APRIL 2022: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT. 175637: LOT 175637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2018. EXPIRATION DATE: 2022-12-05. 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 · 0

    AT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE COMPONENTS WERE LOOSE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294800 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004R 173641 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention