BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLORY-HEAD ACETABULAR SHELL

    MDR report key: 6917192 · Received October 5, 2017

    Report

    Report Number
    3002806535-2017-00915
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Report Date
    January 11, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER WHO HAS REPORTED AS FOLLOWS: THE DEVICES HAVE BEEN VISUALLY EXAMINED WHICH HAS CONCLUDED THAT DAMAGE TO THE IMPLANT POUCH HAS OCCURRED. THIS IS LIKELY DUE TO THE FINS BREAKING THROUGH THE POUCH, AND AS A RESULT, COMPROMISING THE SECONDARY STERILE BARRIER. A RISK ASSESSMENT USING PRODUCT SALES VERSES COMPLAINTS HAS BEEN COMPLETED AND HAS CONFIRMED THE RISK HAS NOT BEEN EXCEEDED AND THEREFORE THERE IS NO RISK TO PATIENT SAFETY. A NEW REVISED PACKAGING CONFIGURATION WAS INTRODUCED TO UPDATE THE PACKAGING OF THE MALLORY SHELL DEVICES. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINTS DATA BASE FOUND NO COMPLAINTS FOR DAMAGED PACKAGING RECORDED FOR THE NEW PACKAGING CONFIGURATION. IT CAN BE CONCLUDED THAT THE DEVICES RETURNED IN THIS EVALUATION WERE CONFORMING TO PRE-DEFINED PACKAGING SPECIFICATION AT THE TIME OF MANUFACTURE. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INNER POUCHES WERE DAMAGED UPON RECEIPT, PRIOR TO USE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698269 MALLORY-HEAD ACETABULAR SHELL PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 3524052

    Patients

    Seq Age Sex Outcome Treatment
    1