BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 3 R

    MDR report key: 7876585 · Received September 14, 2018

    Report

    Report Number
    3005180920-2018-00681
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825446
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE IMMEDIATELY INVESTIGATED THE CASE AND DETERMINED THAT A MIX-UP BETWEEN ONE COMPONENT OF EACH OF THESE TWO LOTS HAPPENED DURING PACKAGING. WE INSPECTED A UNIT FROM LOT 173033 IN STOCK AND FOUND THE PIECE FROM LOT 173034. WITH THIS, WE HAD FULL CONTROL OVER THE TWO MIXED COMPONENTS. AFTER THIS CONFIRMATION, THE REST OF BOTH LOTS WERE INSPECTED TO CONFIRM THAT THE MIX-UP ONLY INVOLVED ONE PIECE FROM EACH LOT AND ALL WERE CONFORMING. BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2018. LOT 173034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2017. EXPIRATION DATE: 2022-07-04. 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 FEMORAL COMPONENT SIZE 5 L REFERENCE 02.09.2605L (K130299) . LOT 173033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2017. EXPIRATION DATE: 2022-07-04 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 BY PACKAGING AND WASHING MANAGER ON 14 SEPTEMBER 2018 THE PICTURES ATTACHED TO THE COMPLAINT AND THE RETURNED PIECE CONFIRMED THAT THERE WAS A MIX UP. FROM A DOCUMENTAL CONTROL IT WAS NOTICED THAT THE TWO LOTS INVOLVED IN THIS CASE WERE CONSEQUENTLY PROCESSED. INTERVIEWING THE OPERATOR AND CHECKING THE PROCESS IT IS POSSIBLE SUPPOSE THAT THE TWO LOTS WERE PACKAGED IN THE SAME TIME IN THE CLEANING ROOM. DUE TO HUMAN ERROR, THERE WAS A MIX UP A PIECE OF THE TWO LOTS. THE EVENT IS RELATED TO AN HUMAN ERROR, IN FACT THE PROCEDURE REPORTS THE OPERATORS MUST PROCESS LOTS ONE BY ONE.

    Description of Event or Problem · 1

    DURING A SURGERY, THE BOX OF A GMK HINGE FEMUR SIZE 3 RIGHT (CODE 02.09.2603R - LOT 173034) WAS OPENED AND A GMK HINGE FEMUR SIZE 5 LEFT (CODE 02.09.2605L - LOT 173033) WAS FOUND INSIDE. THE SURGEON COMPLETED THE SURGERY IMPLANTING A GMK-HINGE FEMORAL COMPONENT SIZE 4R GIVEN THAT A GMK-HINGE FEMORAL COMPONENT SIZE 3R BACK-UP WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720346 GMK-HINGE FEMORAL COMPONENT SIZE 3 R FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 173034 07630030825446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other