BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION TIBIAL AUGMENTATION SIZE 5/10MM

    MDR report key: 7832919 · Received August 30, 2018

    Report

    Report Number
    3005180920-2018-00639
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825743
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018. LOT 123247A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2014. EXPIRATION DATE: 2019-05-31 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. GMK-REVISION TIBIAL AUGMENTATION SIZE 4/10 MM REFERENCE 02.09.TA410 (K130299) LOT 155951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 NOVEMBER 2015. EXPIRATION DATE: 2020-11-08. 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. VISUAL INSPECTION PERFORMED ON AUG 28, 2018 BY PACKAGING AND WASHING MANAGER: AS VISIBLE IN THE PICTURE INITIALLY PROVIDED AND THEN CONFIRMED THROUGH THE VISUAL INSPECTION OF THE RETRIEVED ITEM, THE PRIMARY STERILITY PACKAGING OF BOTH THE IMPLANTS IS DAMAGED. IT IS LIKELY THAT THE HANDLING ACTIVITIES CAUSED AGGRESSIVE TIBIAL COMPONENT MOVEMENT IN THE PRIMARY STERILITY PACKAGING, CAUSING THE BREAKAGE OF THE PRIMARY BARRIER AND IMPACTING THE SECONDARY STERILITY BLISTER. A NEW PACKAGING CONFIGURATION HAS BEEN DEVELOPED AND AN UPDATED VALIDATION MASTER PLAN HAS BEEN IMPLEMENTED IN ORDER TO HELP PREVENT SIMILAR OCCURRENCES IN THE FUTURE. THE INVOLVED LOTS WERE PACKED WITH THE OLD PACKAGING CONFIGURATION.

    Description of Event or Problem · 1

    THE NURSE TOOK THE SIZE 5 AND THE OUTER PACKAGING WAS COMPLETELY INTACT. HE OPENED THE FOIL OF THE INNER PACKAGING AND FOUND THAT THE INNER PACKAGING WAS OPEN. THE SAME ISSUE WAS FOUND FOR THE SIZE 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673918 GMK-REVISION TIBIAL AUGMENTATION SIZE 5/10MM TIBIAL AUGMENTATION KRO MEDACTA INTERNATIONAL SA 123247A 07630030825743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other