BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-METRIC FEMORAL STEM

    MDR report key: 4093761 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07743
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07741).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON IN (B)(6) 2001. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURE UNDER THE STEM. DURING THE PROCEDURE, THE FEMORAL STEM WAS REMOVED AND IT WAS DISCOVERED THAT THE OSS/COMPRESS TAPER ADAPTER NECESSARY FOR THE REVISION WAS NOT AVAILABLE IN THE OPERATING ROOM. THE PROCEDURE WAS FINISHED USING A NAIL AND SPACERS, HOWEVER, THE PATIENT WILL HAVE TO UNDERGO ANOTHER PROCEDURE IN ORDER TO IMPLANT THE CORRECT COMPONENTS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573139 UNKNOWN BI-METRIC FEMORAL STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention