BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 4092546 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07708
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    April 7, 2014
    Report Date
    August 20, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN FROM CHRONIC TENDINOPATHY. NO IMPLANTS WERE REMOVED; HOWEVER, THE SURGEON PERFORMED AN ILIOPSOAS RELEASE (INVASIVE SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573060 CER BIOLOXD OPTION HD 36MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 949220

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R