BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLORY-HEAD ACETABULAR SHELL 58MM POROUS COATED

    MDR report key: 6994905 · Received November 1, 2017

    Report

    Report Number
    3002806535-2017-00992
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET (B)(4) LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS: THE DEVICE AND PACKAGING FOR THE MLRY-HD RNGLC SHL 58MM/L23 23 SHELL WAS RETURNED AND EVALUATED. VISUAL INSPECTION SHOWED THAT THERE WAS FOREIGN MATERIAL IN THE BOTTOM OF THE CAVITY. BLACK PIECES OF DEBRIS FOUND BETWEEN THE BLISTER WALL AND THE URETHANE FOAM. THE DEVICE BLISTER PACKAGING WAS UNOPENED, WITH TYVEK SECURED AS PER THE WORK INSTRUCTIONS FOR TRAY SEALING. THE DEVICE POUCH WAS UNOPENED AND HAD NO DAMAGE PRESENT. NO DAMAGE TO BLISTER OR CARDBOARD CARTON. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INCOMING INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774091 MALLORY-HEAD ACETABULAR SHELL 58MM POROUS COATED PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3807559

    Patients

    Seq Age Sex Outcome Treatment
    1