BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3

    MDR report key: 14157398 · Received April 20, 2022

    Report

    Report Number
    3005180920-2022-00264
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 MARCH 2022. LOT 2111918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2021. EXPIRATION DATE: 2026-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 2108353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2021. EXPIRATION DATE: 2026-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L (K121416) LOT. 2112443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2021. EXPIRATION DATE: 2026-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2112777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    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 17 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630664 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 2111918 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention