BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 8764312 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00549
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT 170430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUNE-2017. EXPIRATION DATE: 2022-06-06. 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. OTHER DEVICES WERE INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L LOT 186138 (K140826): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2018. EXPIRATION DATE: 2023-10-10. 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 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L LOT 181888 (K121416): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUNE-2018. EXPIRATION DATE: 2023-05-21. 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 02.07.0035RP PATELLA RESURFACING SIZE 3 LOT 186277 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2018. EXPIRATION DATE: 2023-10-01. 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.

    Description of Event or Problem · 1

    REVISION SURGERY FOR INFECTION 6 MONTHS AFTER PRIMARY. THE LINER WAS ALREADY SWAPPED IN A PRECEDENT SURGERY PERFORMED ABOUT 1 MONTH AFTER PRIMARY. ALL DEVICES REVISED SUCCESSFULLY IN A 2 STEP REVISION SURGERY: ALL DEVICES REMOVED AND AN ANTIBIOTIC SPACER IMPLANTED ON THE WEEKEND OF (B)(6) 2019, THE PRECISE DATE IS UNKNOWN. ANTIBIOTIC SPACER AND NEW IMPLANTS INSERTED ON THE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558333 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 170430 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention