BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 14165807 · Received April 21, 2022

    Report

    Report Number
    3005180920-2022-00286
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 MARCH 2022. LOT 182878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2018. EXPIRATION DATE: 2023-JUL-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0002L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L (K121416) LOT. 168710. BATCH REVIEW PERFORMED ON 29 MARCH 2022. LOT 168710: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2017. EXPIRATION DATE: 2022-APR-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT SINCE 2018. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIEZ 2/10 MM L (K121416) LOT. 177381 . BATCH REVIEW PERFORMED ON 31 MARCH 2022. LOT 177381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2018. EXPIRATION DATE: 2023-FEB-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO AN INFECTION IN THE KNEE ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. THE PROSTHESIS WAS REMOVED AND ANTIBIOTICS AND A SPACER WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004270 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202L 182878 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention