BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R

    MDR report key: 14753805 · Received June 21, 2022

    Report

    Report Number
    3005180920-2022-00474
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 MAY 2022: LOT 2101944: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 30 MAY 2022: GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826) LOT. 2011063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2020. EXPIRATION DATE: 2025-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED. BATCH REVIEW PERFORMED ON 30 MAY 2022: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 2011764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2021. EXPIRATION DATE: 2026-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 30 MAY 2022: GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 2102489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 8 MONTHS FROM PRIMARY, THE SURGEON PLANNED TO REMOVE ALL COMPONENTS AND IMPLANT AN ANTIBIOTIC SPACER; HOWEVER, THE SURGEON COULD NOT IMPLANT A SPACER DUE TO THE PRESENCE OF SCAR TISSUE AND THE TIGHTNESS OF THE KNEE. THE PATIENT CURRENTLY HAS NO IMPLANTS IN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162143 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025R 2101944 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention