BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE TIBIAL AUGMENTATION SIZE 5/5MM

    MDR report key: 7837113 · Received August 31, 2018

    Report

    Report Number
    3005180920-2018-00649
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825736
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018. LOT 148090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MARCH 2015 . EXPIRATION DATE: 2020-01-31 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 (2 PIECES INVOLVED IN THIS CASE) OTHERS DEVICES INVOLVED: GMK-HINGE FEMORAL WEDGE POSTERIOR SIZE 5/5 MM REFERENCE 02.05.05PW (K102437). LOT 156184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2016. EXPIRATION DATE: 2020-11-24 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-HINGE OFFSET CONNECTOR 3 MM REFERENCE 02.07.0003 (K102437). LOT 174952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017 EXPIRATION DATE: 2022-11-01 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 INSPECTION PERFORMED BY WASHING AND PACKAGING MANAGER ON 31 AUGUST 2018. TIBIAL AUGMENTATION:AS VISIBLE IN THE PICTURES 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. FEMORAL WEDGES: THE IMPLANT WAS RECEIVED AND THE PACKAGING WAS CONFIRMED TO BE BROKEN, AS IT COULD BE SEEN ALSO FROM THE PICTURE PROVIDED AT THE MOMENT OF THE NOTIFICATION. THE INNER POUCH OF THE PACKAGING CONFIGURATION APPLIED WAS NOT SUFFICIENT TO WITHSTAND THE ANOMALOUS SHIPPING STRESSES EXPERIENCED IN COMBINATION WITH THE WEIGHT AND GEOMETRY OF THE DEVICE. A NEW PACKAGING CONFIGURATION FOR THE FEMORAL WEDGE PRODUCT FAMILY HAS BEEN DEVELOPED AND AN UPDATED VALIDATION MASTER PLAN HAS BEEN IMPLEMENTED IN ORDER TO HELP PREVENT SIMILAR OCCURRENCES IN THE FUTURE. OFFSET CONNECTOR:THE INVOLVED IMPLANT WAS NOT RECEIVED, BUT ONE PICTURE WAS PROVIDED AND THE INNER PACKAGING BREAKAGE WAS CONFIRMED. THE DISPLACEMENT LIKELY OCCURRED DUE TO FORCES EXPERIENCED DURING TRANSPORTATION. THIS IS INDICATED TO CORRELATE TO THE COMBINATION OF THE PACKAGING CONFIGURATION APPLIED AND THE SHORT LENGTH OF THE OFFSET CONNECTOR AS THEY ALLOW MORE DEGREES OF FREEDOM FOR MOVEMENT WITHIN THE PACKAGE. A NEW PACKAGING IS UNDEREVALUATION.

    Description of Event or Problem · 1

    DURING SURGERY IT WAS NOTICED THAT SEVERAL IMPLANTS HAD PACKING DAMAGE. THE SURGEON HAD TO USE SECONDARY IMPLANTS TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681302 GMK-HINGE TIBIAL AUGMENTATION SIZE 5/5MM TIBIAL AUGMENTATION KRO MEDACTA INTERNATIONAL SA 148090 07630030825736

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other