BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 2013638 · Received March 10, 2011

    Report

    Report Number
    1825034-2011-00182
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "PRIMARY TOTAL HIP ARTHROPLASTY WITH AN UNCEMENTED FEMORAL COMPONENT. A LONG TERM STUDY OF THE TAPERLOC STEM". J ARTHROPLASTY 2004;19(2):151-156 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. DATES OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY RH ROTHMAN, J PARVIZI, KS KEISU, WJ HOZACK AND PF SHARKEY MANUFACTURE DATE - UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON A REVIEW OF A JOURNAL ARTICLE REFERENCING A RETROSPECTIVE STUDY OF TOTAL HIP PROCEDURES THAT TOOK PLACE BETWEEN (B)(6) 1986 AND (B)(6) 1987 UTILIZING TAPERLOC FEMORAL STEMS. THE ARTICLE INDICATED THAT ONE REVISION PROCEDURE WAS PERFORMED DUE TO OSTEOLYSIS AND THE FEMORAL STEM WAS REMOVED AND REPLACED. 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