BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 36MM -3 NK

    MDR report key: 4240990 · Received November 10, 2014

    Report

    Report Number
    0001825034-2014-08589
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    April 25, 2011
    Report Date
    November 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK061312
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE 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 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06704 / 06705 AND 08589).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT REVISION (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, METAL POISONING, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE (B)(6) 2008 REVISION WAS DUE TO PAIN. THE PATIENT¿S OPERATIVE REPORT NOTED ACETABULAR COMPONENT HAD SMALL AREA OF BONE INGROWTH. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED ANOTHER REVISION WAS PERFORMED ON (B)(6) 2011 DUE TO PAIN. THE PATIENT¿S OPERATIVE REPORT NOTED OSTEOLYTIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722046 CER BIOLOXD MOD HD 36MM -3 NK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 792310

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R