BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 3/14 MM R E-CROSS

    MDR report key: 19870641 · Received July 31, 2024

    Report

    Report Number
    3005180920-2024-00633
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1/G2: EVENT REPORTED TO MEDACTA INTERNATIONAL BY A MEDACTA USA EMPLOYEE AND NOT BY A SALES AGENT AS REPORTED IN MDR.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 JULY 2024: LOT 2317657: (B)(4) MANUFACTURED AND RELEASED ON 20-JUL-2023. EXPIRATION DATE: 2028-JUL-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2024. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN, DUE TO FALLING AND TEARING THEIR QUAD TENDON. ON (B)(6) 2024, THE SURGEON REPAIRED THE TENDON AND PERFORMED A POLY SWAP. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741525 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 3/14 MM R E-CROSS KNEE TIBAL INSERT JWH MEDACTA INTERNATIONAL SA 2317657

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention