BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 14621593 · Received June 7, 2022

    Report

    Report Number
    3005180920-2022-00430
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2022: LOT 1909440: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 1 YEAR AND A HALF FROM PRIMARY DUE TO INFECTION. PICTURES OF THE EXPLANTED COMPONENTS HAVE BEEN SENT FOR ANALYSIS. NO ELEMENTS RELEVANT FOR THE EVENT CAN BE NOTED ON THE EXPLANTED COMPONENTS. CAUSES FOR INFECTION COULD HAVE BEEN MOST LIKELY RELATED TO FACTORS NOT RELATED TO THE IMPLANT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 13 MAY 2022: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 2003006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2020. EXPIRATION DATE: 2025-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0025L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L (K140826) LOT 2003217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JULY-2020. EXPIRATION DATE: 2025-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT 2005226: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE INFECTION AT 1 YEAR AND 5 MONTHS AFTER PRIMARY. ALL COMPONENTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217725 GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 1909440 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention