BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 RIGHT

    MDR report key: 6245586 · Received January 12, 2017

    Report

    Report Number
    3005180920-2016-00728
    Event Type
    Injury
    Date Received
    January 12, 2017
    Report Date
    January 12, 2017
    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

    THE DATE IN WHICH MEDACTA PRODUCTS WERE REMOVED IS UNKNOWN. ON (B)(6) 2016 THE PATIENT HAD THE SECOND STEP OF THE REVISION. THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT PROSTHESIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEWS PERFORMED ON 09 JANUARY 2017. LOT 154148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 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 PATELLA RESURFACING SIZE 4, CODE 02.07.0036RP, LOT. 150875 (K113571) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 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 6 RIGHT, CODE 02.07.1206R, LOT. 113939 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JANUARY 2012. EXPIRATION DATE: 2016-11-30. 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 INSERT FIXED FLEX 6/13 MM RIGHT, CODE 02.12.0613FR, LOT. 143233 (K140826) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. 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 SAW ANOTHER SURGEON DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30622 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 154148

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention