BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3140834 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01766
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    August 5, 2011
    Report Date
    May 3, 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
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM WHAT WAS REMOVED AND REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2011, AS AN INVOICE FOR THE PRIOR SURGERY ((B)(6) 2011) COULD NOT BE LOCATED. 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: PRODUCT IDENTIFICATION/EXPIRY DATE. MANUFACTURE DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 5 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01762 / 01768).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2002 AND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011, DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, ELEVATED METAL ION LEVELS, LOSS OF RANGE OF MOTION, INSTABILITY, AND INFECTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2011, DUE TO ALLEGATION OF DEHISCENCE OF THE LEFT HIP ABDUCTOR MUSCLES AND FACIA. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT TWO ADDITIONAL REVISION PROCEDURES OCCURRED ON (B)(6) 2011, TO REMOVE AND REPLACE THE MODULAR HEADS FOR UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242028 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R