BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/13 MM RIGHT

    MDR report key: 6260045 · Received January 18, 2017

    Report

    Report Number
    3005180920-2016-00741
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 19, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 JANUARY 2017. LOT 141417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2014. EXPIRATION DATE: 2019-03-31. 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. ON 23 DECEMBER 2016 THE PATIENT MATCH DEPARTMENT PERFORMED A PLANNING REVIEW AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. NO ERRORS HAVE BEEN FOUND IN ANY STEP.

    Description of Event or Problem · 1

    THE PATIENT HAD ANTERIOR KNEE PAIN AFTER HER TOTAL KNEE REPLACEMENT. THE SURGEON DID NOT RESURFACE THE PATELLA DURING THE PRIMARY. THE SURGEON RESURFACED THE PATELLA AND UP-SIZED THE POLY. THE SURGEON SWAPPED THE POLY AS HE FELT THE KNEE HAD LOOSENED SINCE THE PRIMARY SURGERY. SINCE THE KNEE WAS ALREADY EXPOSED, HE TRIALED A THICKER POLY AND FELT IT WOULD BE MORE STABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44836 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/13 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141417

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention