BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE S3 LEFT MEDIAL

    MDR report key: 6812707 · Received August 23, 2017

    Report

    Report Number
    3005180920-2017-00465
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895579
    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 21 AUGUST 2017. LOT 163669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2016. EXPIRATION DATE: 2021-06-12. 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 SIZE S3 LEFT MEDIAL - 8MM, CODE 02.18.IF3.08.LM, LOT. 161220 (K162084) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2016. EXPIRATION DATE: 2021-06-01. 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 SIZE S3 LEFT MEDIAL, CODE 02.18.TF3.LM, LOT. 160685 (K162084) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2016. EXPIRATION DATE: 2021-05-26. 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 COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593840 MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE S3 LEFT MEDIAL ANATOMICAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 163669 07630030895579

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention