BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ILOK PRI TIB TRAY 79MM

    MDR report key: 6941930 · Received October 11, 2017

    Report

    Report Number
    0001825034-2017-08515
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO ZIMMER BIOMET. VISUALLY INSPECTION OF RETURNED PACKAGING FOR PN: 141215 LN: 029780. DETERMINED THAT THE PACKAGING WAS UNSEALED AND DID NOT CONTAIN ANY PARTS. AS THE PACKAGING WAS OPENED AND THE PARTS WERE NOT RETURNED THIS COMPLAINT IS NON-VERIFIABLE. REVIEW OF THE DHR AND XA DETERMINED THAT 8 LOCKING BARS WERE ISSUED TO THIS ORDER. VISUAL INSPECTION OF THE PARTS IN INVENTORY BY A QUALITY ENGINEER AFTER THE FIRST COMPLAINT WAS RECEIVED CONFIRMED THAT LOCKING BARS WERE PACKAGED WITH THE TIBIAL TRAYS. AT THIS TIME A ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. " REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL COMPLAINTS ((B)(4)) THAT WERE INVESTIGATED, AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS THIS ISSUE CANNOT BE CONFIRMED. THE LOCKING BAR MAY HAVE BEEN DISCARDED WITH THE PACKAGING. REVIEW OF DEVICE HISTORY RECORDS FOUND UNRELATED DEVIATION DURING THE MANUFACTURING PROCESS. THE NONCONFORMANCE WAS SCRAPPED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIBIAL TRAY PACKAGE WAS MISSING THE LOCKING BAR. ANOTHER LOCKING BAR WAS OPENED AND IMPLANTED WITH THE SAME TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722043 BIOMET ILOK PRI TIB TRAY 79MM PROTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 029780

    Patients

    Seq Age Sex Outcome Treatment
    1