BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ RIGHT

    MDR report key: 6800100 · Received August 17, 2017

    Report

    Report Number
    3005180920-2017-00447
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    August 17, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    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 17 AUGUST 2017. LOT 152916: (B)(4) ITEMS MANUFACTURED NAD RELEASED ON 03 JUNE 2015. EXPIRATION DATE 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT AY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT, CODE 02.07.1204R, LOT. 150355 (K090988) (B)(4) ITEMS MANUFACTURED NAD RELEASED ON 12 MAY 2015. EXPIRATION DATE 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT AY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM RIGHT, CODE 02.12.0410FR, LOT. 147675 (K121416) (B)(4) ITEMS MANUFACTURED NAD RELEASED ON 28 MAY 2015. EXPIRATION DATE 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT AY SIMILAR REPORTED EVENT. GMK-SPHERE PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 150872 (K090988) (B)(4) ITEMS MANUFACTURED NAD 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 AY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGN OF INFECTION. THE PATIENT WAS POSITIVE FOR STREP. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER ON AN UNKNOWN DATE. ON (B)(6) 2017 THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT MEDACTA PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580582 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 152916 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention