BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 7425014 · Received April 12, 2018

    Report

    Report Number
    3005180920-2018-00234
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    March 16, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016 WE WERE INFORMED THAT ON (B)(6) 2018 THE SPACER WAS REMOVED AND PERMANENT IMPLANTS WERE PUT IN.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 APRIL 2018; LOT 173657: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2017. EXPIRATION DATE: 2022-09-25; 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. TIBIAL INSERT FIXED SPHERE FLEX #3/13 MM R REFERENCE 02.12.0311FR (K140826); LOT 173803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-17; 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. TIBIAL TRAY FIXED CEMENTED # 3 R REFERENCE 02.07.1203R (K090988); LOT 174558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2017 EXPIRATION DATE: 2022-10-03; 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. PRIMARY EXTENSION STEM Ø11MM / L 30 MM REFERENCE 02.07.F11030 (K133630); LOT 157706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2016. EXPIRATION DATE:2021-01-24; 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 2 MONTHS AFTER THE PRIMARY. THE PATIENT WAS (B)(6) FOR (B)(6). THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268175 FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 173657 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention