BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 18450738 · Received January 5, 2024

    Report

    Report Number
    3005180920-2023-01052
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 5, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    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 14 DECEMBER 2023 LOT 1904217: 60 ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2019. EXPIRATION DATE: 2024-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT TWO MONTHS AFTER PRIMARY CEMENTED TKA, ALL IMPLANTS ARE REPORTED MOBILIZED AND EXCHANGED. THIS IS A VERY RARE OCCURRENCE, PARTICULARLY BECAUSE NO CLEAR OR PLAUSIBLE CAUSE HAS BEEN REPORTED. AS NO INFORMATION IS AVAILABLE, NO CONCLUSION CAN BE DRAWN OR INFERRED. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 DECEMBER 2023 GMK-PRIMARY 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 1906042 LOT 1906042: 101 ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2019. EXPIRATION DATE: 2024-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2000629 LOT 2000629: 240 ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS 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
    761184 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 1904217 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention