BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #3/10 MM L

    MDR report key: 10137111 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00323
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09-JUN-2020: LOT 1810372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2019. EXPIRATION DATE: 20.02.2024. 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. LOT 1900408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2019. EXPIRATION DATE: 14.04.2024. 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 PAIN DUE TO FALLING AND FRACTURING BOTH PATELLAE BONES. THE PATIENT ALSO PRESENTED WITH SYNOVITIS. THE SURGEON DEBRIDED THE SOFT TISSUE AND PERFORMED A WASHOUT IN BOTH KNEES. HE ALSO PERFORMED A BILATERAL POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATELLA FRACTURES WERE NOT FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602061 GMK-SPHERE TIBIAL INSERT FIXED FLEX #3/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 1810372 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention