BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ACETABLUAR LINER

    MDR report key: 4150465 · Received October 7, 2014

    Report

    Report Number
    0001825034-2014-07978
    Event Type
    Injury
    Date Received
    October 7, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. INVESTIGATION INTO THIS ISSUE IS ONGOING AND SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT / LOT CODE / EXPIRATION DATE. DATE OF IMPLANT. INITIAL REPORTER INFORMATION. PMA/510(K) NUMBER. MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE ACETABULAR LINER WAS NOTED AS BEING LOOSE DURING A REDUCTION. A REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629555 UNK ACETABLUAR LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R