BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC BIOLOXD OPTION HEAD 28MM

    MDR report key: 2970278 · Received February 20, 2013

    Report

    Report Number
    0001825034-2013-00303
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    October 2, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00302 / 00303 AND 315).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REVISION PROCEDURE INFORMATION, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS. " NUMBER 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-03067 & 00302 / 00303 & 00315).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND REPORTS PATIENT ALLEGATIONS OF TISSUE AND BONE DESTRUCTION, PAIN, DISCOMFORT AND DIFFICULTY WALKING. ADDITIONAL INFORMATION PROVIDED IN PATIENT'S MEDICAL RECORDS CONFIRMS THE INITIAL HIP ARTHROPLASTY PROCEDURE DATE AND THAT SUBSEQUENT REVISION PROCEDURES OCCURRED ON (B)(6) 2012. THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED DURING A REVISION PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION ON (B)(6) 2012 DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND REPORTS PATIENT ALLEGATIONS OF TISSUE AND BONE DESTRUCTION, PAIN, DISCOMFORT AND DIFFICULTY WALKING. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE INITIAL HIP ARTHROPLASTY PROCEDURE DATE AND THAT SUBSEQUENT REVISION PROCEDURES OCCURRED ON (B)(6) 2012. THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH A CERAMIC HEAD DURING THE REVISION PROCEDURE ON (B)(6) 2012. THE CERAMIC HEAD WAS REMOVED AND REPLACED DURING THE REVISION ON (B)(6) 2012 FOR AN UNKNOWN REASON. 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
    73161 CERAMIC BIOLOXD OPTION HEAD 28MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 575830

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R