BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 10464400 · Received August 28, 2020

    Report

    Report Number
    3005180920-2020-00550
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    July 23, 2020
    Report Date
    October 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE 15 SEPTEMBER 2020 MEDACTA USA REPORTED THAT THE DEVICES INVOLVED IN THE COMPLAINT ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 AUGUST 2020: LOT 1905069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2019. EXPIRATION DATE: 2024-09-23. 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. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R (K121416) LOT. 1906101. BATCH REVIEW PERFORMED ON 06 AUGUST 2020: LOT 1906101: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2019. EXPIRATION DATE: 2024-07-16. 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. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 1905256. BATCH REVIEW PERFORMED ON 04 AUGUST 2020: LOT 1905256: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-06. 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

    PATIENT COMPLAINTS OF KNEE PAIN. THE KNEE IS INFECTED. HE ATTENDED STEROID INJECTION. THE PATIENT HAS BEEN REVISED DUE TO INFECTION 6 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928753 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0005R 1905069 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention