BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6224672 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00716
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD ALSO A PRIMARY SURGERY FOR THE LEFT KNEE, NOT INVOLVED IN THIS COMPLAINT, ON 01 JUNE 2015. NO ACTIONS WERE TAKEN FOR THIS KNEE AND NO FURTHER REVISIONS WERE PLANNED. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 20 DECEMBER 2016 AND INCLUDES: THE SURGEON REVISED ONLY THE LINER. THE PATHOGEN WAS NOT YET AVAILABLE. BATCH REVIEW PERFORMED ON 29 DECEMBER 2016. LOT 150466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HEMATOGENE INFECTION WAS DETECTED DURING A REGULAR CONTROL. PAIN AS THE TRIGGER AS WELL AS SWELLING. THE RIGHT KNEE WAS REVISED WITH DEBRIDEMENT, WASHING AND INLAY CHANGE. ANTIBIOTIC THERAPY FORESEEN AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10310 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 150466

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention