BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR LINER

    MDR report key: 3013503 · Received March 20, 2013

    Report

    Report Number
    0001825034-2013-00658
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 6, 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
    FL, 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 1999; HOWEVER, AN EXACT DATE WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN APPROXIMATELY 1999. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO POLYETHYLENE LINER WEAR. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN APPROXIMATELY 1999. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6 2013 DUE TO POLYETHYLENE LINER WEAR. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116543 UNKNOWN ACETABULAR LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R