BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD TOTAL HIP SYSTEM

    MDR report key: 6513113 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02697
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    September 29, 2015
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS - CER OPT TYPE 1 TPR SLEVE 0MM/ PN 650-1066/ LN 6473250, CER BIOLOXD OPTION HD 28MM/ PN 650-1055/ LN 231660, UNKNOWN STRYKER SHELL, UNKNOWN BEARING . ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. REVIEW OF THE STERILIZATION CERTIFICATE FOR ALL THE REPORTED PRODUCTS IN THE EVENT IDENTIFIED THE PRODUCTS HAVE LEFT THE ZIMMER BIOMET MANUFACTURING SITE STERILE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND POSSIBLE INFECTION AND/OR LOOSENING APPROXIMATELY EIGHT YEARS POST-IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND POSSIBLE INFECTION OR STEM LOOSENING APPROXIMATELY EIGHT YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293271 MALLORY-HEAD TOTAL HIP SYSTEM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 008790

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SEE H10 NARRATIVE