BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE 0

    MDR report key: 3182015 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02100
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 22, 2012
    Report Date
    May 28, 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
    AL, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 6 OF 8 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02095 / 02102). 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 REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DIFFICULTY AMBULATING AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS, METALLOSIS, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE ON (B)(6) 2002 AND ON RIGHT SIDE ON (B)(6) 2003. FURTHER REVIEW CONFIRMS REVISION PROCEDURES WERE PERFORMED ON RIGHT SIDE ON (B)(6) 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283321 CER OPTION TYPE 1 TPR SLEVE 0 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 447140

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R