BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R

    MDR report key: 15282570 · Received August 24, 2022

    Report

    Report Number
    3005180920-2022-00640
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 24, 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 04 AUGUST 2022 LOT 2010191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2020. EXPIRATION DATE: 2025-11-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. IMPLANTED ADDITIONAL COMPONENTS: BATCH REVIEW PERFORMED ON 04 AUGUST 2022 ON GMK-SPHERE 02.12.0513FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R (K140826) LOT. 1811505: LOT 1811505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 04 AUGUST 2022 ON GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 2009497: LOT 2009497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JAN-2021. EXPIRATION DATE: 2026-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434161 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025R 2010191 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention