BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 11481956 · Received March 15, 2021

    Report

    Report Number
    3005180920-2021-00217
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 3 MARCH 2021: LOT 1900310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2019. EXPIRATION DATE: 2024-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 3 MARCH 2021: GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L (K121416) LOT. 178750. LOT 178750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-MAR-2018. EXPIRATION DATE: 2023-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L (K090988) LOT. 182894. LOT 182894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2018. EXPIRATION DATE: 2023-09-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381119 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025L 1900310 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention