BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 4103068 · Received September 19, 2014

    Report

    Report Number
    0001825034-2014-07817
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 AND POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY IN 2007 AND A LEFT HIP ARTHROPLASTY IN 2002. PATIENT ALLEGES NECROSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY OCCURRED (B)(6) 2007. AN INVOICE FOR THE 2002 PROCEDURE COULD NOT BE LOCATED. THERE HAS BEEN NO REVISION PROCEDURE REPORTED TO DATE FOR THE LEFT HIP. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, SURGEON ALLEGEDLY NOTED THE PRESENCE OF METAL. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. PATIENT FURTHER ALLEGES PAIN AND DIFFICULTY FOLLOWING THE REVISION PROCEDURE. 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
    582351 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 960410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization