BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHER TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 13468777 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00076
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    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 (B)(6) 2022 LOT 1910197: 125 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: (B)(6) 2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR SECONDARY RESURFACING OF PATELLA FEW YEARS AFTER PRIMARY TKA IN AN ELDERLY WOMAN. THE POSITION OF THE PATELLAR BONE IN THE PRE-REVISION XRAY DEMANDS THAT SURGERY BE UNDERTAKEN. THERE IS NO REASON TO SUSPECT THAT THIS REOPERATION WAS DETERMINED BY A DEFECTIVE DEVICE AMONG THOSE IMPLANTED IN THE PRIMARY TREATMENT.

    Description of Event or Problem · 0

    PATIENT NATURAL PATELLA LUXATED. THE PATIENT HAD TO GO ADDITIONAL SURGERY FOR PATELLA RESURFACING. KNEE WAS A BIT LAX SO INLAY WAS REVISED TO A THICKER ONE. PRIMARY DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505712 GMK-SPHER TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 1910197 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention