BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/12 MM RIGHT

    MDR report key: 6819956 · Received August 25, 2017

    Report

    Report Number
    3005180920-2017-00471
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 25, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826986
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THIS PATIENT. HE HAD THE PRIMARY SURGERY (NO PATELLA REPLACEMENT) ON (B)(6) 2016. THE PATIENT CAME IN COMPLAINING OF PAIN. ON (B)(6) 2017 THE PATIENT CAME IN FOR A PATELLA REPLACEMENT. THEN, HE CAME IN AGAIN FOR POSSIBLE INFECTION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: THE PATHOGEN IS CONFIRMED AS STREPTOCOCCUS AGALATACIAE. BATCH REVIEW PERFORMED ON 22 AUGUST 2017. LOT 153313: 25 ITEMS MANUFACTURED AND RELEASED ON 05 NOVEMBER 2015. EXPIRATION DATE: 2020-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION FOR POSSIBLE INFECTION. THE SURGEON REPLACED THE TIBIAL INSERT AND WENT UP FROM A 12MM POLY TO A 14MM POLY. HE FELT THE KNEE WAS MORE STABLE WITH A SLIGHTLY THICKER INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602013 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/12 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 153313 07630030826986

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention