BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L

    MDR report key: 20133229 · Received September 4, 2024

    Report

    Report Number
    3005180920-2024-00690
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 4, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711449
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 AUG 2024. LOT 2304419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-06-05. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.28T3I4L GMK-SPHERE TIBIAL TRAY CEMENTED T3I4L TINBN COATED (K202684) LOT 2300306: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2023. EXPIRATION DATE: 2028-06-07. 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. GMK-SPHERE 02.12.E0411FL TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L E-CROSS (K202022) LOT 2307914: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2023. EXPIRATION DATE: 2028-04-25. 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

    AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108129 GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2304419 07630040711449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention