BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    MDR report key: 17734995 · Received September 13, 2023

    Report

    Report Number
    3005180920-2023-00694
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-AUG-2023: LOT 2000475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2020. EXPIRATION DATE: 2025-04-19. 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. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 20-AUG-2023: GMK-SPHERE 02.12.0517FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM L (K121416) LOT 1900401: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-04-24. 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. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT 2001511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2020. EXPIRATION DATE: 2025-05-14. 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. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT 2001620: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2020. EXPIRATION DATE: 2025-05-05. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE POLY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING DIRECTLY ON THE KNEE, WHICH CAUSED THE INSERT TO DISENGAGE FROM THE BASEPLATE. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED SUCCESSFULLY NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643221 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 2000475 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention