BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #6/10 MM LEFT

    MDR report key: 6669346 · Received June 27, 2017

    Report

    Report Number
    3005180920-2017-00339
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826931
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 14 JUNE 2017 THE PATIENT MATCH DEPARTMENT REVIEWED THE PLANNING OF THIS CASE AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. THE PROBLEM MENTIONED IN THE COMPLAINT (DETACHMENT OF THE FIXATING SCREW) IS, ANYWAY, NOT IMPUTABLE TO THE PLANNING PROCESS. NO EXTRA-ANALYSIS IS POSSIBLE, SINCE NO X-RAY IS AVAILABLE. BATCH REVIEW PERFORMED ON 26 JUNE 2017. LOT 163060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016. EXPIRATION DATE: 2021-07-20. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IN UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON STATED THAT NOTHING WAS VISIBLE ON THE X-RAYS, SOMEHOW THE KNEE STRETCHED OUT AND THE POLY IS TO BE UPSIZED FROM A 10 TO A 17 IN ORDER FOR THE KNEE TO BECOME STABLE AGAIN. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450698 GMK-SPHERE TIBIAL INSERT FIXED FLEX #6/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 163060 07630030826931

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention