BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMESH RT SZ24 HA FLANGE ACET

    MDR report key: 3892424 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05754
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK983035
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "SENSITIVITY REACTIONS IN PATIENTS FOLLOWING JOINT REPLACEMENT HAVE RARELY BEEN REPORTED.'

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY TO IMPLANT A CUSTOM TRIFLANGE ACETABULAR COMPONENT ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ACETABULAR OSTEOLYSIS. THE CUSTOM TRIFLANGE WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY TO IMPLANT A CUSTOM TRIFLANGE ACETABULAR COMPONENT ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE TO REPLACE THE TRIFLANGE COMPONENT HAS BEEN INDICATED. THERE HAS BEEN NO REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368010 LEMESH RT SZ24 HA FLANGE ACET PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 333780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R