BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM

    MDR report key: 10389664 · Received August 11, 2020

    Report

    Report Number
    3005180920-2020-00508
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896712
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 160681: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-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 OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM LOT. 163668 (K162084). BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 163668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-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 OTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF2.09.LM TIBIAL INSERT FIX S2 LM - 9MM LOT. 161245 (K162084). BATCH REVIEW PERFORMED ON 24 JULY 2020: LOT 161245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-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 OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REPLACED THE UNI IMPLANTS AND IMPLANTED A TKA 2 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853920 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM TIBIAL TRAY FIX CEMENTED PARTIAL HSX MEDACTA INTERNATIONAL SA 02.18.TF2.LM 160681 07630030896712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention