BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS MODULAR DISTAL FEMUR IMPLANT

    MDR report key: 4373082 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00179
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. HOWEVER ON COMPLETION OF THE INVESTIGATION INTO THE REPORTED EVENT IT CAN NOW BE CONCLUDED THAT THE INCIDENT DOES NOT MEET THE THREE BASIC REPORTING CRITERIA REFERENCED IN 21 CFR PART 803 AS A MARKETED DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR A MARKETED DEVICE HAS NOT MALFUNCTIONED WHERE THE MALFUNCTION OF THE DEVICE OR A SIMILAR MARKETED DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA: COMMON DEVICE NAME/PRODUCT CODE CORRECTED FROM DISTAL FEMUR IMPLANT/KRO" TO "LIMB SALVAGE SYSTEM/KRO".

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DETAILS CONFIRMED THAT THE COMPONENT HAD BEEN MANUFACTURED USING THE CORRECT PROCESS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS BATCH, THEREFORE IT IS BEING TREATED AS AN ISOLATED EVENT. 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

    IT WAS REPORTED BY THE SURGEON THAT THE INNER PACKAGING OF THE DEVICE WAS DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AS THE DEVICE WAS STILL ABLE TO BE USED AND WAS IMPLANTED WITH NO FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE INNER PACKAGING OF THE DEVICE WAS DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AS THE DEVICE WAS STILL ABLE TO BE USED AND WAS IMPLANTED WITH NO FURTHER COMPLAINTS. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00179 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851636 METS MODULAR DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD B10858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other