BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

    MDR report key: 10755026 · Received October 29, 2020

    Report

    Report Number
    3005180920-2020-00750
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895586
    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 189249: 48 ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 02-MAR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT. MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM LOT. 189256 (K162084). BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 189256: 50 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 17-FEB-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF4.09.RM TIBIAL INSERT FIX S4 RM - 9MM LOT. 189282 (K162084) BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 189282: 35 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2019. EXPIRATION DATE: 26-MAR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 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 REPORTING PAIN 11 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL MOTO IMPLANTS TO SPHERE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224326 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM ANATOMICAL FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 02.18.003RM 189249 07630030895586

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention