BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP COMPONENTS

    MDR report key: 3013513 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00659
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PRODUCT IDENTIFICATION/EXPIRY DATE; DATE IMPLANTED - THE REPORTED DATE OF IMPLANTATION WAS 2003; HOWEVER, AN EXACT DATE WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN APPROXIMATELY 2003. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO WEAR. THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116065 UNKNOWN HIP COMPONENTS PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R