BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    MDR report key: 13769980 · Received March 15, 2022

    Report

    Report Number
    3005180920-2022-00179
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 16, 2022
    Report Date
    March 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 1905117: (B)(4). EXPIRATION DATE: 2024-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 18 FEBRUARY 2022: GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 (K121416) LOT 171814: (B)(4). EXPIRATION DATE: 2022-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 2011075: (B)(4). EXPIRATION DATE: 2026-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4).

    Description of Event or Problem · 0

    HOLD FOR KP 3.15THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND REVISED THEM WITH COMPETITOR COMPONENTS 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38711 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0210FR 1905117 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention