BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HR004, S/M ALEXIS ORTHO PROT 5/BX

    MDR report key: 6091292 · Received November 9, 2016

    Report

    Report Number
    2027111-2016-00726
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    February 15, 2016
    Report Date
    January 16, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915123185
    PMA / PMN Number
    K100120
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. BASED ON THE CUSTOMER PROVIDED DESCRIPTION, IT IS POSSIBLE THAT THE SHEATH WAS TORN DURING PLACEMENT OF THE BIOMET CUP. HOWEVER, SINCE THE UNIT WAS NOT RETURNED, THE EXACT ROOT CAUSE CANNOT BE CONFIRMED. APPLIED MEDICAL REACHED OUT TO THE HOSPITAL AND SURGEON TO PROVIDE INFORMATION REGARDING USE OF THE DEVICE TO PREVENT FURTHER RECURRENCES. ALL ALEXIS ORTHOPAEDIC PROTECTORS ARE 100% INSPECTED DURING THE MANUFACTURING PROCESS. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    CORRECTION - DATE RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    LATERAL HIP REPLACEMENT- "THE ALEXIS ORTHO WAS PLACED CORRECTLY, BUT DURING THE PROCEDURE THERE WERE LITTLE TEARS IN THE SHEAT OF THE ALEXIS. THE TEARS VARIED FROM 2MM TO 2CM. THE TEARS STARTED TO SHOW AFTER THE BIOMET CUP HAD BEEN PLACED." PATIENT STATUS: "NO PATIENT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739544 HR004, S/M ALEXIS ORTHO PROT 5/BX KGW KGW APPLIED MEDICAL RESOURCES HR004 1249866 00607915123185

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOMET CUP