BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT

    MDR report key: 6431439 · Received March 24, 2017

    Report

    Report Number
    3005180920-2017-00124
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 20 MARCH 2017. LOT 160118: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2016. EXPIRATION DATE: 2021-03-14. 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 5 LEFT, CODE 02.07.1205L, LOT. 162180 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2016. EXPIRATION DATE: 2021-05-16. 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. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM LEFT, CODE 02.12.0511FL, LOT. 154749 (K140826) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 DECEMBER 2015. EXPIRATION DATE: 2020-11-25. 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. 164135 (K113571) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS STAPHYLOCOCCUS AUREUS. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214937 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 160118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention