BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 32IDX48OD

    MDR report key: 6903923 · Received September 29, 2017

    Report

    Report Number
    1818910-2017-25699
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    UDI-DI
    10603295016151
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION AND LOOSENING OF THE POLY AT THE BONE TO IMPLANT INTERFACE. IT WAS INDICATED THAT THE POLY WAS OUT OF CUP AND IT'S POSSIBLE THE POLY WAS NEVER FULLY SEATED. UPDATE 8/313/2017 IT WAS REPORTED THAT THE LINER DISASSOCIATED FROM THE CUP. OTHER DETAILS WITHIN THE DER APPEAR TO BE IN ERROR RELATED TO THIS REPORT. THE LINER, BY DEFINITION, CANNOT BE LOOSE AS AN IMPLANT IS LOOSE, BEING THAT IT TYPICALLY ISN'T CEMENTED, AND IT CANNOT INTERFACE WITH BONE BEING THAT IT IS NON-POROUS COATED. THE COMPLAINT WILL ADDRESS THE DISASSOCIATION SPECIFICALLY. COMPLAINT UPDATED ON: 9/25/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683732 ALTRX +4 10D 32IDX48OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC.1818910 238218 10603295016151

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention