BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS

    MDR report key: 15579655 · Received October 11, 2022

    Report

    Report Number
    3005180920-2022-00774
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 20, 2022
    Report Date
    October 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260979
    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 22 SEPTEMBER 2022. LOT 2012664: 65 ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-DEC-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT (SAME PATIENT, PREVIOUS REVISION SURGERY) DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING LOOSENESS AFTER DISLOCATING THE PATELLA. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L -10MM WITH A GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L -14MM AND REPOSITIONED THE PATELLA WITH SOFT TISSUE REPAIR. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING LOOSENESS AFTER DISLOCATING THE PATELLA AGAIN. THE SURGEON DECIDE TO REVISE ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360788 GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS PATELLA RESURFACING E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E001RP 2012664 07630971260979

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention