BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R

    MDR report key: 9449585 · Received December 11, 2019

    Report

    Report Number
    3005180920-2019-01059
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 20, 2019
    Report Date
    December 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON DECEMBER 09TH 2019: LOT 1765556: 33 ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2018. EXPIRATION DATE: 18.12.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEWS PERFORMED ON DECEMBER 09TH 2019: GMK-SPHERE 02.12.0413FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R (K140826) LOT 176181: 25 ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2018. EXPIRATION DATE: 21.12.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 182906: 104 ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2018. EXPIRATION DATE: 12.09.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 100 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION, 1 YEAR AFTER PRIMARY. ALL HARDWARE HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246444 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R KNEE FEMORAL IMPLANT JWH MEDACTA INTERNATIONAL SA 176556 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention