BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 RM - 8MM

    MDR report key: 10776752 · Received November 3, 2020

    Report

    Report Number
    3005180920-2020-00772
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895883
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 167782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2017. EXPIRATION DATE: 2021-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON (B)(6) 2020: MOTO PARTIAL KNEE 02.18.002RM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM (K162084) LOT 173332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.TF2.RM TIBIAL TRAY FIX CEMENTED S2 RM (K162084) LOT 170790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2017. EXPIRATION DATE: 2022-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS ESCHERICHIA COLI. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED A FEMORAL COMPONENT AND INSERT WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247477 MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 RM - 8MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF2.09.RM 167782 07630030895883

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention