BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 4092553 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07713
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    November 26, 2013
    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07713 /-07714).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED AND AN IRRIGATION & DEBRIDEMENT WERE PERFORMED ON (B)(6) 2013 DUE TO A NON-HEALING SURGICAL WOUND. THE PRESENCE OF A HEMATOMA WAS NOTED DURING THE REVISION PROCEDURE. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. REVIEW OF INVOICE HISTORY VERIFIED THE IMPLANT AND REVISION SURGERY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573550 CER BIOLOXD OPTION HD 36MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 695600

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R