BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L

    MDR report key: 7634070 · Received June 25, 2018

    Report

    Report Number
    3005180920-2018-00459
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    May 28, 2018
    Report Date
    July 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825873
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 ABOUT 1 YEAR AND 1 MONTH AFTER SPACER IMPLANTATION, ON (B)(6) 2019, THE ANTIBIOTIC SPACER WAS REMOVED AND PERMANENT HARDWARE WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JUNE 2018. LOT 155735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JANUARY 2016. EXPIRATION DATE: 2020-12-07. 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. GMK-SPHERE PRIMARY EXTENSION STEM Ø11MM / L 30 MM REFERENCE (B)(4): LOT 162050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE: 2021-04-11 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. GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L REFERENCE (B)(4): LOT 152438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 NOVEMBER 2015. EXPIRATION DATE: 17.10.2020. 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. GMK-SPHERE PATELLA RESURFACING SIZE 4 REFERENCE (B)(4): LOT 160955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2016. EXPIRATION DATE: 21.04.2021 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. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L REFERENCE (B)(4): LOT 156425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2016. EXPIRATION DATE: 2021-04-11. 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 HAD A PRIMARY ON (B)(6) 2016. ON (B)(6) 2017 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION [PATHOGEN NOT AVAILABLE]. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. (MDR 2017-00602) ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. PATHOGEN UNKNOWN. THE SURGEON PULLED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478422 FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 155735 07630030825873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention