BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY 02.07.0510SF TIBIAL INSERT STD FIXED SIZE 5 / 10 MM

    MDR report key: 17649538 · Received August 30, 2023

    Report

    Report Number
    3005180920-2023-00659
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818240
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2208437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-JUN-2022. EXPIRATION DATE: 2027-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT 2205926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT 2114777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2022. EXPIRATION DATE: 2027-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT 2205015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2022. EXPIRATION DATE: 2027-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS 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 A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE SURGEON REPORTS THAT THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IS PRESENTING SIGNS OF AN INFECTION. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, FEMORAL COMPONENT AND PATELLA COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679347 GMK-PRIMARY 02.07.0510SF TIBIAL INSERT STD FIXED SIZE 5 / 10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2208437 07630030818240

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention