BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    MDR report key: 8050708 · Received November 8, 2018

    Report

    Report Number
    3005180920-2018-00863
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    September 28, 2016
    Report Date
    October 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 NOVEMBER 2018. LOT 160050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2016. EXPIRATION DATE: 2021-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R REFERENCE 02.07.1203R (K090988). LOT 160578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2016 . EXPIRATION DATE: 2021-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON NOVEMBER 07, 2018. 2 YEARS AFTER PRIMARY CEMENTED TKA A PARTIAL REVISION IS REQUIRED DUE TO ANTERIOR KNEE PAIN. ONLY PARTIAL RADIOGRAPHS ARE AVAILABLE, THAT DO NOT ALLOW TO EVALUATE THE RATIONALE BEHIND THE CORONAL ORIENTATION OF THE PROSTHESIS. IN THE PRE-REVISION IMAGE, THE PATELLA SEEMS TO BE LOCATED ON THE MEDIAL EDGE OF THE TROCHLEA, AND THIS, ALONG WITH AN UNDEFINED ROTATION OF THE FEMORAL COMPONENT, MAY RESULT IN ANTERIOR PAIN. WE SEE NO REASON TO SUSPECT THAT A FAULTY DEVICE ORIGINATED THIS PROBLEM. PRELIMINARY INVESTIGATION PERFORMED ON NOVEMBER 08, 2018 BY R&D PRODUCT MANAGER: REVISION SURGERY AFTER 2 YEARS FROM PRIMARY IMPLANTATION FOR ANTERIOR KNEE PAIN. PICTURES OF THE EXPLANTED TIBIAL INSERT AND TRAY HAVE BEEN SENT. LOOKING AT THOSE PICTURE, ANY ELEMENTS THAT COULD BE RELATIVE TO THE EVENT CAN'T BE IDENTIFIED. WE CAN'T SEE ANY REASONS THAT COULD LEAD THINK THAT THE EVENT IS DUE TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 2 YEARS AND 1 MONTH AFTER PRIMARY SURGERY DUE TO ANTERIOR KNEE PAIN. PATELLA AND TIBIA WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891261 TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 160050 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention