BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 3102937 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01351
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH INFORMATION PROVIDED DATE IMPLANTED - 1995. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00520-1 & 01349/1351).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 1995. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. IT WAS NOTED THAT X-RAYS APPEARED TO SHOW THE CEMENT MANTLE APPEARED FRACTURED IN THE FEMUR. THE STEM, HEAD, LINER AND CEMENT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204510 UNKNOWN BONE CEMENT BONE CEMENT LOD BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R