BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    MDR report key: 9238376 · Received October 25, 2019

    Report

    Report Number
    3005180920-2019-00898
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    September 26, 2019
    Report Date
    October 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 4 OCTOBER 2019: LOT 173638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4 OCTOBER 2017. EXPIRATION DATE: 2022-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR TWO YEARS AFTER PRIMARY CMENTED TKA A NECROSIS OF THE PATELLA, TO OUR KNOWLEDGE COMPLETELY UNRELATED TO THE PREVIOUS INTERVENTION, LED TO KNEE INSTABILITY. REVISION WAS REQUIRED TO PROVIDE INTRINSIC STABILITY TO THE JOINT AS THE PATELLAR SYSTEM COULD NOT CONTRIBUTE ANY LONGER. THIS PROBLEM IS UNRELATED TO THE EXISTING TKA. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT. 171885. BATCH REVIEW PERFORMED ON 4 OCTOBER 2019: LOT 171885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3 MAY 2017. EXPIRATION DATE: 2022-05-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 174558. BATCH REVIEW PERFORMED ON 4 OCTOBER 2019: LOT 174558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2017. EXPIRATION DATE: 2022-10-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO KNEE INSTABILITY CAUSED BY A PATELLA NECROSIS. THE REASON OF PATELLA NECROSIS IS UNKNOWN (NO INFECTION PRESENT). THE SURGEON REVISED THE INSERT AND FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031563 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 173638 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention