BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

    MDR report key: 18613588 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00010
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261730
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 JANUARY 2024. LOT 2112621: 25 ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2021. EXPIRATION DATE: 2026-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 19 JANUARY 2024 ON GMK-SPHERE 02.12.E002RP PATELLA RESURFACING SIZE 2 E-CROSS (K202022) LOT. 2242107 LOT 2242107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 104 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 19 JANUARY 2024 ON GMK-SPHERE 02.12.0724L FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L (K202684) LOT. 2205191, LOT 2205191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2022. EXPIRATION DATE: 2027-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 19 JANUARY 2024 ON GMK-SPHERE 02.07.2804L TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED (K202684) LOT. 2118549, LOT 2118549: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2022. EXPIRATION DATE: 2027-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246745 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2112621 07630971261730

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention