BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R

    MDR report key: 8420968 · Received March 14, 2019

    Report

    Report Number
    3005180920-2019-00153
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 14, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 180414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. OTHER DEVICES WERE INVOLVED IN THE COMPLAINT AND DETAILS ARE REPORTED HERE BELOW. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED # 5 R LOT. 176249 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2017. EXPIRATION DATE: 2022-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. GMK-SPHERE 02.12.0024R FEMORAL COMPONENT SPHERE CEMENTED # 4+ R LOT. 174843 (K140826): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2017. EXPIRATION DATE: 2022-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, ONE MONTH AND A HALF AFTER PRIMARY SURGERY, THE PATIENT PRESENT SIGNS OF INFECTION. I&D AND POLY SWAP HAVE BEEN PERFORMED (COMPLAINT (B)(4). PRESENTLY, 4 MONTHS LATER, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). A WASHOUT AND REVISION OF THE TIBIAL INSERT, TIBIAL TRAY AND FEMORAL COMPONENT HAVE BEEN PERFORMED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212820 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 180414 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention