BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION TIBIAL AUGMENTATION SIZE 3/10MM

    MDR report key: 6724704 · Received July 19, 2017

    Report

    Report Number
    3005180920-2017-00390
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 19, 2017
    Report Date
    July 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825705
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 19 JULY 2017. LOT 123245A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 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 FEMORAL WEDGE POSTERIOR SIZE 3/10MM, CODE 02.07.310FPW, LOT. 135785 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2014. EXPIRATION DATE: 2018-12-31. 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 19JULY 2017 THE CLEANING AND PACKAGING MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE PICTURES AND COMMENTED AS FOLLOWS: - WEDGE: AS VISIBLE IN THE ATTACHED PICTURE THE PACKAGING IS DAMAGED. THE NATURE OF THE DAMAGE PRESENTS, AS VISUALLY EVIDENT, ALLOWING THE SURGEON TO USE ANOTHER FEMORAL WEDGE. THE INNER POUCH OF THIS PACKAGING CONFIGURATION WAS NOT SUFFICIENT TO WITHSTAND THE ANOMALOUS SHIPPING STRESSES EXPERIENCED IN COMBINATION WITH THE WEIGHT AND GEOMETRY OF THE DEVICE. - TIBIAL AUGMENTATION: AS VISIBLE IN THE ATTACHED PICTURE THE PRIMARY STERILITY PACKAGING 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.

    Description of Event or Problem · 1

    WHEN THE TIBIAL AUGMENT WAS OPENED, IT WAS NOTICED THAT THE INTERNAL PACKAGING WAS PUNCTURED. THE SURGEON BELIEVED THE STERILITY WAS NOT COMPROMISED SO HE DECIDED TO IMPLANT THE SUBJECT TIBIAL AUGMENT. ALSO, THE PACKAGING OF THE POSTERIOR FEMORAL WEDGE FOUND WAS FOUND TORN. THE SURGEON DID NOT IMPLANT THE SUBJECT POSTERIOR FEMORAL WEDGE AS HE THOUGHT THE STERILITY MAY BE COMPROMISED. THE SURGEON PROCEEDED USING A SECOND IMPLANT (DIFFERENT SIZE) TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507478 GMK-REVISION TIBIAL AUGMENTATION SIZE 3/10MM TIBIAL AUGMENTATION KRO MEDACTA INTERNATIONAL SA 123245A 07630030825705

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other