BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 10640900 · Received October 7, 2020

    Report

    Report Number
    3005180920-2020-00681
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    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 ON 07.OCTOBER.2020: LOT 1903588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03.JUL.2019. EXPIRATION DATE: 15.JUN.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 07.OCTOBER.2020. GMK-SPHERE 02.12.0210FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R (K121416) LOT 1905117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13.SEP.2019. EXPIRATION DATE: 01.SEP.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 1906228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04.DEC.2019. EXPIRATION DATE: 20.NOV.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT 1905064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23.SEP.2019. EXPIRATION DATE: 11.SEP.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED A MEDACTA INSERT AND FEMUR WITH ANTIBIOTIC CEMENT 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104802 GMK-SPHERE PATELLA RESURFACING SIZE 2 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0034RP 1903588 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention