BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

    MDR report key: 13415523 · Received February 1, 2022

    Report

    Report Number
    3005180920-2022-00057
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 4, 2022
    Report Date
    February 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030895609
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 JANUARY 2022: LOT 2007537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 11 JANUARY 2022: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084) LOT 2009942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2020. EXPIRATION DATE: 2025-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF5.08.RM TIBIAL INSERT FIX S5 RM - 8MM (K162084) LOT 2009911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2020. EXPIRATION DATE: 2025-11-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS, PERFORMED A WASHOUT AND IMPLANTED A TOTAL SEMI-COSTAINED SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504217 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM KNEE FEMUR IMPLANT JWH MEDACTA INTERNATIONAL SA 02.18.004RM 2007537 07630030895609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention