BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    MDR report key: 5597309 · Received April 22, 2016

    Report

    Report Number
    3005180920-2016-00178
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 25, 2016
    Report Date
    July 22, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 APRIL 2016. LOT 154697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 T3-I4, CODE 02.12.T3I4L, L LOT. 153117 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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 FLEX SIZE 4/10 MM LEFT, CODE 02.12.0410FL, LOT. 153533 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF AN INFECTION. THE SURGEON REMOVED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY. THE INSERT AND FEMORAL COMPONENT WERE REPLACED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254649 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 154697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention