BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 1912967 · Received December 2, 2010

    Report

    Report Number
    1825034-2010-00640
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 7, 2010
    Manufacturer
    BIOMET UK LTD
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE PRODUCT IDENTIFICATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. DATE OF EVENT - UNKNOWN. THE ONLY INFORMATION RECEIVED IS THAT THE FRACTURES OCCURRED TEN DAYS INTO REHABILITATION. EXPIRATION DATE - UNKNOWN. NO PRODUCT IDENTIFICATION RECEIVED. DATE IMPLANTED - NO INFORMATION PROVIDED FOR EITHER EVENT. DATE EXPLANTED - NO INFORMATION PROVIDED FOR EITHER EVENT. MANUFACTURE DATE - UNKNOWN. NO PRODUCT IDENTIFICATION RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT IDENTIFICATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE COMPONENTS WERE NOT MANUFACTURED BY BIOMET ORTHOPEDICS, INC. THESE WERE MANUFACTURED AT BIOMET (B)(4) AND THE FOLLOWING MEDWATCH NUMBERS WERE MAILED TO THE FDA ON BEHALF OF BIOMET (B)(4): 3002806535-2011-00003 & 3002806535-2011-00004. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS UNDERWENT HIP ARTHROPLASTY AND SUBSEQUENTLY EXPERIENCED PERIPROSTHETIC FRACTURE OF THE STEM TEN DAYS INTO REHABILITATION. IT IS UNKNOWN IF A REVISION PROCEDURE HAS BEEN PERFORMED ON EITHER PATIENT. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS UNDERWENT HIP ARTHROPLASTY AND SUBSEQUENTLY EXPERIENCED PERIPROSTHETIC FRACTURE OF THE STEM TEN DAYS INTO REHABILITATION. IT IS UNKNOWN IF A REVISION PROCEDURE HAS BEEN PERFORMED ON EITHER PATIENT. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R