BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R

    MDR report key: 10567153 · Received September 22, 2020

    Report

    Report Number
    3005180920-2020-00632
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862458
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2020: LOT 173655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2017. EXPIRATION DATE: 2022-10-18. 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. OTHER DEVICES INVOLVED IN THE EVENT GMK-SPHERE 02.12.0110CRR TIBIAL INSERT FIXED SPHERE CR #1/10 MM R LOT. 185604 (K181635) BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2020: LOT 185604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2018. EXPIRATION DATE: 2023-09-05. 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 02.07.1201R TIBIAL TRAY FIXED CEMENTED # 1 R LOT. 177227 (K090988) BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2020: LOT 177227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2018. EXPIRATION DATE: 2023-01-23. 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 REPORTING INSTABILITY DUE TO DEVELOPING A MEDIAL COLLATERAL LIGAMENT RUPTURE. THE CAUSE OF THE RUPTURE IS UNKNOWN. 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034672 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0021R 173655 07630030862458

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention