BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ LEFT

    MDR report key: 6511282 · Received April 21, 2017

    Report

    Report Number
    3005180920-2017-00189
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    April 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 21 APRIL 2017: LOT 162664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2016. EXPIRATION DATE: 2021-05-02. 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 4 LEFT, CODE 02.07.1204L, LOT. 162034 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE: 2021-05-10. 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 4/13 MM LEFT, CODE 02.12.0413FL, LOT. 152433 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JULY 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 PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 161545 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2016. EXPIRATION DATE: 2021-05-30. 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. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS CONFIRMED AS CORYNEBACTERIUM AND STAPHYLOCOCCUS EPIDERMIDIS. THE SURGEON REVISED ALL COMPONENT AND IMPLANTED AN ANTIBIOTIC SPACER. THE DATE IN WHICH THE COMPONENTS WERE REMOVED IS UNKNOWN. ON (B)(6) 2017, THE SURGEON REVISED THE SPACER WITH REVISION IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292780 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ LEFT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 162664

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention