BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 28MM DIAMETER MINUS 6 NECK

    MDR report key: 2231841 · Received September 1, 2011

    Report

    Report Number
    1825034-2011-00772
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    June 27, 2009
    Report Date
    August 8, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS IS MDR THREE OF THREE (1825034-2011-00770 THROUGH 00772) FOR THIS EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT SUBMITTED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LEGAL COMPLAINT THAT PATIENT UNDERWENT HEMI-ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT'S HIP DISLOCATED AND A CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6) 2009. AN OPEN REDUCTION WAS THEN PERFORMED ON (B)(6) 2009, WITH THE MODULAR HEAD BEING REMOVED AND REPLACED, AFTER PATIENT'S HIP DISLOCATED AGAIN. ON (B)(6) 2009, THE PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT REPORTEDLY EXPIRED ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED VIAL LEGAL COMPLAINT THAT PATIENT UNDERWENT HEMI-ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT'S HIP DISLOCATED AND A CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6), 2009. AN OPEN REDUCTION WAS THEN PERFORMED ON (B)(6), 2009, WITH THE MODULAR HEAD BEING REMOVED AND REPLACED, AFTER PATIENT'S HIP DISLOCATED AGAIN. ON (B)(6), 2009, THE PATIENT WAS REVISED WITH ALL COMPONENTS REMOVED AND REPLACED, DUE TO DISLOCATION. PATIENT REPORTEDLY EXPIRED ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD COMPONENT 28MM DIAMETER MINUS 6 NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 023660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R