BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD PF SOLID RINGLOC ACETABULAR SHELL

    MDR report key: 2122275 · Received June 13, 2011

    Report

    Report Number
    1825034-2011-00505
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    K921181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 1997. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN AND A CYST BEHIND THE ACETABULAR CUP. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY HEAD PF SOLID RINGLOC ACETABULAR SHELL PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R