BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD RADIAL 3-HOLE ACETABULAR SHELL 50MM/POROUS

    MDR report key: 2689867 · Received August 10, 2012

    Report

    Report Number
    0001825034-2012-01254
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    June 5, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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." AND 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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01252 / 01255).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXPLANT DATE SHOULD BE LEFT BLANK. IMPLANT WAS NOT REVISED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01252-1 / 01255-1).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO ALLEGED PAIN AND METALLOSIS. 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 TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012. MEDICAL RECORDS PROVIDED INDICATE REVISION WAS ALLEGEDLY DUE TO ELEVATED COCR LEVELS, PAIN, INFECTION, AND METALLOSIS. THE HEAD AND STEM WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE SHELL AND LINER REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD RADIAL 3-HOLE ACETABULAR SHELL 50MM/POROUS PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 547840

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R