BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 15037298 · Received July 18, 2022

    Report

    Report Number
    3005180920-2022-00534
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2102542: 125 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 106 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959790 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 2102542 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention