BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R

    MDR report key: 15679055 · Received October 27, 2022

    Report

    Report Number
    3005180920-2022-00812
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 7, 2022
    Report Date
    October 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 OCTOBER 2022: LOT 1901896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2019. EXPIRATION DATE: 2024-MAY-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. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 13 OCTOBER 2022: GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX #5/11 MM R (K140826) LOT 187988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2019. EXPIRATION DATE: 2024-JAN-09. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942745 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0025R 1901896 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention