BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / RIGHT

    MDR report key: 11548782 · Received March 23, 2021

    Report

    Report Number
    3005180920-2021-00225
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821035
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05.MAR.2021: LOT 150972A: 1 ITEM MANUFACTURED AND RELEASED ON 9-MAR-2020. EXPIRATION DATE: 2025-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0412PSF TIBIAL INSERT PS FIXED SIZE 4/12MM (K090988) LOT. 179573 BATCH REVIEW PERFORMED ON 05.MAR.2021: LOT 179573: 75 ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 64 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 1909610 BATCH REVIEW PERFORMED ON 05.MAR.2021: LOT 1909610: 132 ITEMS MANUFACTURED AND RELEASED ON 6-APR-2020. EXPIRATION DATE: 2025-03-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2000628 BATCH REVIEW PERFORMED ON 05.MAR.2021: LOT 2000628: 240 ITEMS MANUFACTURED AND RELEASED ON 3-MAR-2020. EXPIRATION DATE: 2025-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 224 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452847 GMK-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / RIGHT CEMENTED KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2216R 150972A 07630030821035

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention