BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RLOC LNR 10D/HWL 23

    MDR report key: 5812878 · Received July 21, 2016

    Report

    Report Number
    0001825034-2016-02702
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 30, 2016
    Report Date
    June 23, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 18 YEARS POST-IMPLANTATION DUE TO WEAR OF THE ACETABULAR LINER. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465562 ARCOM 28MM RLOC LNR 10D/HWL 23 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 741370

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R