BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM

    MDR report key: 9334341 · Received November 18, 2019

    Report

    Report Number
    3005180920-2019-00980
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826665
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 154783: 50 ITEMS MANUFACTURED AND RELEASED ON 20 JAN 2016. EXPIRATION DATE: 2021-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 182015. BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 182015: 140 ITEMS MANUFACTURED AND RELEASED ON 8 MAY 2018. EXPIRATION DATE: 2023-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 130 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT. 180377. BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 180377: 117 ITEMS MANUFACTURED AND RELEASED ON 23 APR 2018. EXPIRATION DATE: 2023-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 108 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416) LOT. 180366. BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 180366: 71 ITEMS MANUFACTURED AND RELEASED ON 16 APR 2018. EXPIRATION DATE: 2023-04-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.0033RP PATELLA RESURFACING SIZE 1 (K090988) LOT. 180308. BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 180308: 130 ITEMS MANUFACTURED AND RELEASED ON 8 MAY 2018. EXPIRATION DATE: 2023-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 124 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY PERFORMED 9 MONTHS AFTER THE FIRST REVISION SURGERY DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A NEW FEMUR AND INSERT TO ACT AS A SPACER. THE FIRST REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION (INSERT REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132747 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 154783 07630030826665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention