BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC STEM 12X140

    MDR report key: 3021803 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00729
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    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." 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 14 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
    124605 BI-METRIC/X POR NC STEM 12X140 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 092080

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R