BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4364957 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00101
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    July 23, 2013
    Report Date
    July 23, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO A MANUFACTURING ISSUE. ON INITIAL RECEIPT OF THE REPORTED EVENT, THE EVENT DESCRIPTION WAS REVIEWED AND WITH THE LIMITED INFORMATION AVAILABLE AT THAT TIME, A DECISION WAS MADE TO REPORT THE EVENT. CORRECTED DATA: COMMON DEVICE NAME/PRODUCT CODE CORRECTED FROM "PROSTHESIS, KNEE, FEMEROTIBIAL, CONS" TO "LIMB SALVAGE SYSTEM/KRO".

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE PACKAGING OF AN INDIVIDUAL METS COMPONENT WAS LOOSER THAN USUAL AND THERE WAS AIR PRESENT AND UPON OPENING THAT PACKAGING COULD BE EASILY REMOVED. DESPITE THIS THE PACKAGING WAS STILL SEALED AND THE SURGEON DETERMINED THAT THE DEVICE WAS SAFE FOR USE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PACKAGING OF AN INDIVIDUAL METS COMPONENT WAS LOOSER THAN USUAL AND THERE WAS AIR PRESENT AND UPON OPENING THAT PACKAGING COULD BE EASILY REMOVED. DESPITE THIS THE PACKAGING WAS STILL SEALED AND THE SURGEON DETERMINED THAT THE DEVICE WAS SAFE FOR USE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00101 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838349 METS DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD MKFE/LSTD/A10002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R