BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ARTICULATION E1 28MM ID X 50MM OD

    MDR report key: 3021820 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00728
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." 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. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 13 OF 14 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00716 / 00729).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT RIGHT HIP WAS REVISED ON (B)(6) 2012 AND THE LEFT HIP WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF BILATERAL PAIN, A PSEUDOTUMOR, ELEVATED COCR LEVELS, INFLAMMATION, SWELLING, BONE/TISSUE DAMAGE AND LACK OF MOBILITY. FOLLOWING THE REVISION PROCEDURES, PATIENT ALLEGES INFECTION AND DISLOCATIONS RESULTING IN DEBRIDEMENT, PLACEMENT OF A PICC LINE, HOSPITALIZATIONS AND OUTPATIENT THERAPY AND TREATMENT. 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
    124786 ACTIVE ARTICULATION E1 28MM ID X 50MM OD PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 668330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R