BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/H IMPACT DISTAL STEM 12MMX120MM

    MDR report key: 2942192 · Received February 4, 2013

    Report

    Report Number
    0001825034-2013-00190
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    June 23, 2011
    Report Date
    January 7, 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
    MA, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." 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 (B)(4). THIS REPORT IS NUMBER 1 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00190 / 00196).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON (B)(6) 2003 AND THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011, DUE TO PAIN METALLOSIS, INFECTION AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY AND MEDICAL RECORDS CONFIRMS BOTH SURGERY DATES AND THAT ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS DURING THE REVISION ON (B)(6) 2011. MEDICAL RECORDS INDICATE THAT A LEFT TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED IN 2008; HOWEVER, IT IS UNKNOWN IF BIOMET PRODUCTS WERE WERE IMPLANTED IN 2008. 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
    46189 R/H IMPACT DISTAL STEM 12MMX120MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 316470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R