BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RLOC LINER 10D/HWL 22

    MDR report key: 4997317 · Received August 12, 2015

    Report

    Report Number
    0001825034-2015-03603
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 23, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK950761
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    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.

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO POLY WEAR RESULTING IN INSTABILITY. THE HEAD AND LINER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO POLY WEAR; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530921 ARCOM 28MM RLOC LINER 10D/HWL 22 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 374860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention