BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 HIWALL LINER SZ24

    MDR report key: 4061473 · Received September 4, 2014

    Report

    Report Number
    0001825034-2014-07525
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "ACETABULAR SCREWS ARE TO BE FULLY SEATED TO ASSURE STABLE FIXATION AND TO AVOID INTERFERENCE WITH THE ACETABULAR LINER COMPONENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO A DAMAGED ACETABULAR LINER AND MODULAR HEAD AS A RESULT OF THE ACETABULAR LINER NOT BEING FULLY LOCKED INTO THE ACETABULAR CUP WHEN INITIALLY IMPLANTED. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THE SCREW WAS NOT FULLY SEATED IN THE CUP WHICH WOULD HAVE PREVENTED THE ACETABULAR LINER LOCKING INTO THE CUP. THE SCREW WAS FULLY SEATED INTO THE CUP AND ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542217 E-POLY 40MM +3 HIWALL LINER SZ24 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 955550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R