BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6819952 · Received August 25, 2017

    Report

    Report Number
    3005180920-2017-00470
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 AUGUST 2017. LOT 141017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF THE INSTABILITY WAS LIGAMENTS STRETCHING OVER TIME. THE SURGEON RESURFACED THE PATELLA AND SWAPPED THE POLY. THE POLY EXCHANGE WAS A 10MM TO A 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602007 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141017 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention