BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L

    MDR report key: 13567342 · Received February 21, 2022

    Report

    Report Number
    3005180920-2022-00130
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826931
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 FEBRUARY 2022: LOT 1902487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2019. EXPIRATION DATE: 2024-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 FEBRUARY 2022: LOT 1902487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2019. EXPIRATION DATE: 2024-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED COMPONENTS: 02.12.E0610FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6L -10MM 2012410. 02.07.0034RP PATELLA RESURFACING S2 2111891.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED COMPONENTS: 02.12.E0610FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6L -10MM 2012410. 02.07.0034RP PATELLA RESURFACING S2 2111891.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401225 GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0610FL 1902487 07630030826931

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention