BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L E-CROSS

    MDR report key: 15319890 · Received August 30, 2022

    Report

    Report Number
    3005180920-2022-00656
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261518
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-AUG-2022. LOT 2109013: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2021. EXPIRATION DATE: 2026-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: GMK-SPHERE 02.12.E001RP PATELLA RESURFACING SIZE 1 E-CROSS (K202022) LOT. 2012664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY. THE PATELLA WAS ALSO DISLOCATED AND IT WAS FIXED WITH SOFT TISSUE REPAIR. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142997 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0310FL 2109013 07630971261518

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention