BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LINER HIWALL 25

    MDR report key: 2894034 · Received January 3, 2013

    Report

    Report Number
    0001825034-2012-02670
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 6, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    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 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT/EVENT (REFERENCE 1825034-2012-02669 / 02672). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02669 / 02672).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT ALLEGES PAIN. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3099 ARCOM 28MM RNGLOC LINER HIWALL 25 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 572570

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability