BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R

    MDR report key: 9416399 · Received December 5, 2019

    Report

    Report Number
    3005180920-2019-01037
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    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 14 NOVEMBER 2019. LOT 173819: 25 ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 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 COMPLAINING OF ANTERIOR KNEE PAIN AND INSTABILITY. THE SURGEON RESURFACED THE PATELLA, AND REVISED THE SPHERE INSERT FLEX RIGHT 12MM S5 TO A SPHERE INSERT FLEX RIGHT 14MM S5 FOR MORE STABILITY, 1 YEAR 9 MONTHS AND A HALF AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210834 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 173819 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention