BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 2/12 MM R

    MDR report key: 11271429 · Received February 3, 2021

    Report

    Report Number
    3005180920-2021-00083
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707244
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 JANUARY 2021: LOT 185611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2018. EXPIRATION DATE: 2023-09-10. 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 ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 JANUARY 2021: GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R (K140826) LOT 162678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2016. EXPIRATION DATE: 2021-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND SWELLING IN THE KNEE 7 MONTHS AFTER THE PRIMARY. INFECTION EXCLUDED, THE CAUSE OF THE PAIN AND SWELLING IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172842 GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 2/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0212CRR 185611 07630040707244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention