BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RIGHT-MEDIAL

    MDR report key: 6803618 · Received August 18, 2017

    Report

    Report Number
    3005180920-2017-00452
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    July 21, 2017
    Report Date
    August 18, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895623
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 18 AUGUST 2017. LOT 163688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2016. EXPIRATION DATE: 2021-06-15. 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 - TIBIAL TRAY FIX CEMENTED S6 RIGHT-MEDIAL, CODE 02.18.TF6.RM, LOT. 160699 (K162084) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2016. EXPIRATION DATE: 2021-05-29. 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 - TIBIAL INSERT FIX S6 - 8MM RIGHT-MEDIAL, CODE 02.18.IF6.08.RM, LOT. 161238 (K162084) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2016. EXPIRATION DATE: 2021-06-08. 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 DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED ANOTHER PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583147 MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RIGHT-MEDIAL ANATOMICAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 163688 07630030895623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention