BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15666143 · Received October 25, 2022

    Report

    Report Number
    3005180920-2022-00793
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-OCT-2022: LOT 1910682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2020. EXPIRATION DATE: 2025-01-08. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 2 YEARS AFTER PRIMARY TKA IN A 75 YEAR OLD WOMAN, PATELLA PAIN AND LACK OF STABILITY LEAD TO REVISION SURGERY. THIS WAS LIKELY DUE TO DISEASE PROGRESSION, BOTH FOR THE SECONDARY INSTABILITY, NORMALLY DUE TO LIGAMENT RELAXATION, AND FOR THE PATELLAR PAIN, PROBABLY DUE TO ARTHROSIS OF THE PATELLAR BONE. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS REVISION.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO PAIN AND LAXITY ABOUT 2 YEARS AFTER THE PRIMARY SURGERY. PATELLA BONE RESURFACED AND INLAY CHANGED WITH A THICKER ONE (FROM 10 TO 12 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628393 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 1910682 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention