BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    MDR report key: 8591157 · Received May 8, 2019

    Report

    Report Number
    3005180920-2019-00348
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 MAY 2019: LOT 180351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2018. EXPIRATION DATE: 2023-05-07. 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. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416), LOT 180974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-31. 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 02.12.0411FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R (K140826), LOT 181898: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN AND INSTABILITY CAUSED BY A CONNECTIVE TISSUE DISORDER. THE SURGEON REVISED THE GMK SPHERE FEMORAL COMPONENT, LINER AND TIBIAL TRAY WITH A GMK HINGE FEMORAL COMPONENT, LINER AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384898 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 180351 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention