BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 13770435 · Received March 15, 2022

    Report

    Report Number
    3005180920-2022-00189
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    October 22, 2021
    Report Date
    March 15, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 24 FEBRUARY 2022: LOT 2103463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-28. 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 DEVICES INVOLVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT. 2005227: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 23-JULY-2020. EXPIRATION DATE: 2025-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT. 2012086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-28. 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 HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE SPACER REMOVED AND PERMANENT HARDWARE IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38016 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0024R 2103463 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention