BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY PATELLA RESURFACING SIZE 3

    MDR report key: 15444688 · Received September 19, 2022

    Report

    Report Number
    3005180920-2022-00718
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 AUGUST 2022. LOT 2012792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-03-01. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT AT 1 YEAR AFTER PRIMARY TKA WITH PATELLA RESURFACING, THE PATELLAR IMPLANT MOBILIZES AND NEEDS REPLACEMENT. IT IS POSSIBLE THAT AN OSTEOPHYTE, GENERATED AT APPROX. 6 MONTHS AFTER INDEX SURGERY, CONTRIBUTED TO THE LOOSENING, BUT THIS CANNOT BE DETERMINED. THE OTHER COMPONENTS WERE WELL FIXED AND THE JOINT WAS STABLE. WE CANNOT DETERMINE THE ROOT CAUSE FOR MOBILIZATION OF THE PATELLA.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR 4 MONTHS AFTER THE PRIMARY FOR PATELLA LOOSENING. NO INFECTION. NO TRAUMA DESCRIBED BY THE PATIENT BUT PAINFUL KNEE. NO LOOSENING OF THE OTHER COMPONENTS. THE PRESENCE OF AN OSTEOPHYTE WAS DISCOVERED ON THE X-RAYS THAT APPEARED AT ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON SUCCESSFULLY REMOVED THE OSTEOPHYTE AND REVISED PATELLA WITH A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428511 GMK-PRIMARY PATELLA RESURFACING SIZE 3 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0035RP 2012792 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention