BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    MDR report key: 10647766 · Received October 8, 2020

    Report

    Report Number
    3005180920-2020-00682
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 8, 2020
    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 16 SEPTEMBER 2020: LOT 1902413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2019. EXPIRATION DATE: 2024-06-29. 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 ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 16 SEPTEMBER 2020: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT. 1903262. LOT 1903262: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUNE-2019. EXPIRATION DATE: 2024-06-09. 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. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 1902701. LOT 1902701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-30. 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.

    Description of Event or Problem · 1

    KNEE REVISION SURGERY 11 MONTHS AFTER PRIMARY. BEFORE THE REVISION SURGERY THE BACTERIOLOGICAL TESTS WERE POSITIVE TO ((B)(6)). THE SURGEON REVISED SUCCESSFULLY THE KNEE FEMUR AND TIBIAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116047 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003R 1902413 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention