BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 1

    MDR report key: 12597524 · Received October 8, 2021

    Report

    Report Number
    3005180920-2021-00788
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 SEPTEMBER 2021: LOT 180307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APRIL-2018. EXPIRATION DATE: 2023-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 3 YEARS AFTER TRI-COMPARTMENTAL TKA THE PATELLAR BONE GOT NECROTIC AND THE ARTIFICAL PATELLA GOT LOOSE. IT WAS REMOVED AND NOT SUBSTITUTED. THIS ADVERSE EVENT DID NOT ORIGINATE FROM A DEVICE DEFICIENCY.

    Description of Event or Problem · 1

    PATELLAR MOBILIZATION DUE TO PATELLAR BONE NECROSIS. REMOVAL OF PATELLAR IMPLANT WITHOUT REPLACEMENT. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495454 GMK-SPHERE PATELLA RESURFACING SIZE 1 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 180307 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention