BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROCOAT STEMMED TIBIAL COMPONENT

    MDR report key: 5160207 · Received October 20, 2015

    Report

    Report Number
    2648920-2015-00379
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Removal / Correction Number
    2648920-11-25-2015-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00598603701, NEXGEN STEMMED TIBIAL COMPONENT, LOT #62460315; IMPLANTED ON (B)(6) 2015. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED PHOTOS SHOWS THE PACKAGE FOR A NEXGEN PRECOAT TIBIAL COMPONENT, SIZE 3 (P/N: 00-5980-037-01, L/N: 62491580). PHOTOS OF THE DEVICE SHOW THAT IT WAS A NEXGEN OPTION TIBIAL COMPONENT, SIZE 3 (P/N: 00-5986-037-01, L/N: 62460315). REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENTS IDENTIFIED THAT BOTH LOTS WENT THROUGH THE SEAL AND PACKAGE OPERATION ON THE SAME DATE AND WERE PROCESSED BY THE SAME OPERATORS, INDICATING A COMMINGLING OF THE UNITS. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE RELATED PART AND LOT COMBINATIONS. STOCK INVESTIGATION IDENTIFIED NO UNITS FROM EITHER LOT WERE REMAINING IN INVENTORY. THE TWO AFFECTED LOTS ARE BEING REMOVED FROM THE FIELD. THIS FIELD ACTION HAS BEEN REPORTED TO THE FDA UNDER 2648920-11-25-2015-002-R. PREVIOUS CAPAS WERE COMPLETED FOR SIMILAR ISSUES AND DEFINED CORRECTIVE ACTIONS CONCERNING COMMINGLING INCIDENTS. THESE CAPAS HAVE BEEN CLOSED AND THE CORRECTIVE ACTIONS WERE IMPLEMENTED BETWEEN THE DATES OF MARCH 1, 2014 AND JUNE 30, 2015. THE AFFECTED LOTS WERE MANUFACTURED IN SEPTEMBER OF 2013, PREVIOUS TO CAPA IMPLEMENTATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIBIAL BASEPLATE INSIDE THE BOX DID NOT MATCH THE LABELING ON THE BOX. THE PATIENT WAS IMPLANTED WITH THE TIBIAL BASEPLATE FOUND INSIDE THE PACKAGING, AS NO OTHER COMPONENTS WERE AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692220 NEXGEN PROCOAT STEMMED TIBIAL COMPONENT JWH JWH ZIMMER 62491580

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR