BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 2013591 · Received March 10, 2011

    Report

    Report Number
    1825034-2011-00160
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "A SHORT TERM SOLUTION: THROUGH SMALL PORTALS". ORTHOPEDICS 2009;32(9):663. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE REVISION MENTIONED IN THE JOURNAL ARTICLE. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY AV LOMBARDI JR., KR BEREND, AND JB ADAMS. MANUFACTURE DATE - UNKNOWN. THIS REPORT FILED MARCH 10, 2011.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE REFERENCING A RETROSPECTIVE STUDY OF HIP PROCEDURES THAT TOOK PLACE BETWEEN (B)(6) 2003 AND (B)(6) 2008 UTILIZING TAPERLOC MICROPLASTY FEMORAL COMPONENTS. THE ARTICLE INDICATED THAT A REVISION WAS PERFORMED THE SAME DAY AS THE INITIAL PROCEDURE DUE TO PERFORATION OF THE POSTERIOR FEMORAL CORTEX DURING PREPARATION. THE FEMORAL STEM WAS REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R