BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM

    MDR report key: 10101058 · Received May 29, 2020

    Report

    Report Number
    3005180920-2020-00302
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895593
    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 22 MAY 2020: LOT 182110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2018. EXPIRATION DATE: 2023-05-28. 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. LOT 170793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2017. EXPIRATION DATE: 2022-06-08. 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. LOT 167800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2017. EXPIRATION DATE: 2021-12-12. 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.

    Description of Event or Problem · 1

    THE SURGEON REVISED THE MOTO KNEE TO A SPHERE KNEE AND RESURFACED THE PATELLA 8 MONTHS AFTER PRIMARY. THE REASON FOR THE REVISION WAS THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564439 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM PARTIAL KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 02.18.004LM 182110 07630030895593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention