BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVR ANATOMIC STANDARD RIGHT

    MDR report key: 3113780 · Received May 15, 2013

    Report

    Report Number
    0001825034-2013-01516
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE COULD NOT DETERMINE ROOT CAUSE OF REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. ("DEPUY") ON (B)(4) 2012 ("CLOSING DATE"). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT DISTAL RADIUS FRACTURE FIXATION PROCEDURE (B)(6) 2012. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013, TO REMOVE THE IMPLANTS. AS THE SURGEON REMOVED THE IMPLANTS, A BLACK FIBRINOUS TISSUE WAS DISCOVERED SURROUNDING THE PLATE. FOLLOWING REVISION, PATIENT DEVELOPED THE APPEARANCE OF A SUPERFICIAL HYPERSENSITIVITY TYPE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214009 DVR ANATOMIC STANDARD RIGHT PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A RM496B

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization