BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    MDR report key: 11037586 · Received December 18, 2020

    Report

    Report Number
    3005180920-2020-00911
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 18, 2020
    Report Date
    March 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE AN ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON PLANNED TO REVISE THE TIBIAL COMPONENT AND POLY ON (B)(6) 2020, 2 YEARS AND 1 MONTH AFTER PRIMARY, BUT THE CASE HAD TO BE POSTPONED DUE TO THE PATIENT GOING INTO ATRIAL ATRIAL FIBRILLATION JUST PRIOR TO THE START OF THE CASE. REVISION SURGERY HAS NOT BEEN PERFORMED YET.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE AN ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON PLANNED TO REVISE THE TIBIAL COMPONENT AND POLY ON (B)(6) 2020, 2 YEARS AND 1 MONTH AFTER PRIMARY, BUT THE CASE HAD TO BE POSTPONED DUE TO THE PATIENT GOING INTO ATRIAL ATRIAL FIBRILLATION JUST PRIOR TO THE START OF THE CASE. REVISION SURGERY HAS NOT BEEN PERFORMED YET.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 NOVEMBER 2020: LOT 180377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2018. EXPIRATION DATE: 2023-04-13. 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 REPORTING INSTABILITY DUE AN ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON PLANNED TO REVISE THE TIBIAL COMPONENT AND POLY ON (B)(6) 2020, 2 YEARS AND 1 MONTH AFTER PRIMARY, BUT THE CASE HAD TO BE POSTPONED DUE TO THE PATIENT GOING INTO ATRIAL FIBRILLATION JUST PRIOR TO THE START OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501407 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other