BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 23

    MDR report key: 3120147 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01566
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00832-1 AND 01566).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222457 ARCOM 28MM RNGLOC LNR HWALL 23 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 086740

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R