BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 28IDX48OD

    MDR report key: 3965019 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24393
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    PK062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2014, DOR: (B)(6) 2014 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4) DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: WRIGHT MEDICAL . EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT. 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

    PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440829 ALTRX NEUT 28IDX48OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC.1818910 443646

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention