BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2 E-CROSS

    MDR report key: 15509028 · Received September 29, 2022

    Report

    Report Number
    3005180920-2022-00735
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260986
    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 13 SEPTEMBER 2022. LOT 2012665: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-27. 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 2 MONTHS AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER A PHYSICAL THERAPY SESSION. THE PATIENT HAD ALSO SOME GAIT ISSUES. THE SURGEON NOTED THAT THE CUT PERFORMED DURING THE PRIMARY WAS NOT THE BEST SO HE DECIDED TO REVISE THE PATELLA IMPLANT AND RECUT THE PATELLA TO GIVE A DIFFERENT ORIENTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615887 GMK-SPHERE PATELLA RESURFACING SIZE 2 E-CROSS KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.12.E002RP 2012665 07630971260986

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention