BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 22 POLY LINER HI-WALL

    MDR report key: 3033758 · Received April 3, 2013

    Report

    Report Number
    0001825034-2013-00831
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. PMA/510(K) NUMBER / MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO POLY WEAR. THE HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136417 SIZE 22 POLY LINER HI-WALL PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R