BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/20 MM R

    MDR report key: 16362565 · Received February 13, 2023

    Report

    Report Number
    3005180920-2023-00041
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826504
    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 17 JANUARY 2023. LOT 2000440: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MARCH-2020. EXPIRATION DATE: 2025-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THE ITEM INVOLVED IN THE COMPLAINT HAS BEEN SOLD DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R (K140826) LOT 2112027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS AFTER THE PRIMARY KNEE SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED FEMUR AND LINER (20 TO 26 MM) AND DECIDED TO CONVERT THE PATIENT TO A SEMI-CONSTRAINED CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387134 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/20 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0320FR 2000440 07630030826504

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention