BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMET MODULAR HEAD 28MM +3

    MDR report key: 3033832 · Received April 3, 2013

    Report

    Report Number
    0001825034-2013-00809
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. IMPLANT DATE - UNKNOWN. PMA/510(K) NUMBER/ MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2013 DUE TO LINER DISLOCATION. COMPETITOR'S LINER AND BIOMET MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136996 UNK - BIOMET MODULAR HEAD 28MM +3 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R