BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 10217918 · Received July 1, 2020

    Report

    Report Number
    3005180920-2020-00369
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 2, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 12 JUNE 2020: LOT 1900539: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R (K121416) LOT. 1811504. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 12 JUNE 2020: LOT 1811504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826) LOT. 1900333. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 12 JUNE 2020: LOT 1900333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2019. EXPIRATION DATE: 2024-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN 10 MONTHS AFTER THE PRIMARY SURGERY POSSIBLY DUE TO AN OVERSIZED TIBIA OR UNDERSIZED FEMUR. THE SURGEON REVISED THE SIZE 5 TIBIAL TRAY WITH A SIZE 4 TIBIAL TRAY, THE SIZE 5+ FEMORAL COMPONENT WITH A SIZE 5 FEMORAL COMPONENT AND SIZE 5/12MM INSERT WITH A SIZE 4/20MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683664 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R FIXED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1205R 1900539 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention