BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL TRAY SIZE 3 LEFT - FINISHING

    MDR report key: 19826861 · Received July 25, 2024

    Report

    Report Number
    3005180920-2024-00547
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819360
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 JULY 2024 LOT 2215011: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-27. 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. ADDITIONAL IMPLANTS REVISED BATCH REVIEW PERFORMED ON 3 JULY 2024 ON GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 10 MM (K103170) LOT. 2010895 LOT 2010895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2021. EXPIRATION DATE: 2025-12-29. 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. BATCH REVIEW PERFORMED ON 3 JULY 2024 ON GMK-REVISION 02.07.FCL12150 FLUTED EXTENSION STEM Ø12MM / L 150MM (K120790) LOT. 189576 LOT 189576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2019. EXPIRATION DATE: 2024-01-14. 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. BATCH REVIEW PERFORMED ON 3 JULY 2024 ON GMK-REVISION 02.09.TA305 TIBIAL AUGMENTATION SCREWED S3 - 5 MM (K130299) LOT. 2240424 LOT 2240424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2022. EXPIRATION DATE: 2027-11-22. 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. BATCH REVIEW PERFORMED ON 3 JULY 2024 ON GMK-REVISION 02.09.TA310 TIBIAL AUGMENTATION SCREWED S3 - 10 MM (K130299) LOT. 2109504 LOT 2109504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2021. EXPIRATION DATE: 2026-10-03. 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 SHIN PAIN AND THE CAUSE WAS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AUGMENTS AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTES: PATIENT EXPRESSED SHIN PAIN FROM THE 11X150 STEM EXTENSION. THE ORIGINAL TIBIAL COMPONENT WITH TIBIAL AUGMENTS, AND STEM EXTENSION WERE REMOVED. A SHORT STEM EXTENSION WAS UTILIZED WITH ORIGINAL SIZE AUGMENTS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303934 GMK-REVISION TIBIAL TRAY SIZE 3 LEFT - FINISHING KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2215011 07630030819360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention