BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R L

    MDR report key: 7199218 · Received January 17, 2018

    Report

    Report Number
    3005180920-2017-00843
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17JANUARY 2018 LOT 165065: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 OCT 2016. EXPIRATION DATE: 2021-09-22 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 SIZE3/10 MM R REFERENCE 02.12.0310FR (K121416): LOT 165076: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2016. EXPIRATION DATE:2021-09-07 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. TIBIAL TRAY FIXED CEMENTED SIZE 3 R REFERENCE 02.07.1203R (K090988): LOT 164893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPT 2016. EXPIRATION DATE: 2021-09-19 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. PATELLA RESURFACING # 2 REFERENCE 02.07.0034RP (K090988): LOT 163383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPT 2016. EXPIRATION DATE: 2021-09-19 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

    REVISION SURGERY 1 YEAR AFTER PRIMARY WAS NECESSARY DUE TO INFECTION. THE PATHOGEN RESULT IS NOT AVAILABLE. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45495 FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 165065 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention