BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 14545879 · Received May 31, 2022

    Report

    Report Number
    3005180920-2022-00412
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    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 04 MAY 2022. LOT 2111925: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2021. EXPIRATION DATE: 2026-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 2112779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2021. EXPIRATION DATE: 2026-11-28. 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 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT 2105301: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUNE-2021. EXPIRATION DATE: 2026-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN. THE SURGEON DECIDED TO REVISE THE PATIENT AND DISCOVERED THAT TIBIA, FEMUR AND PATELLA WERE LOOSE AND DID NOT BOND WITH THE CEMENT. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS ALMOST 2 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660605 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2111925 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention