BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 14998485 · Received July 13, 2022

    Report

    Report Number
    3005180920-2022-00518
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022, LOT 2012008: LOT 2012008: 80 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2025-DEC-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 73 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022 GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416), LOT 2012086: LOT 2012086: 87 ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-APR-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2022 GMK-SPHERE 02.12.0412FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R (K121416), LOT 2009032: LOT 2009032: 75 ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-OCT-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669957 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004R 2012008 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention