BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+5

    MDR report key: 3770167 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17428
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    August 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS PSEUDOTUMORS. INFECTION WAS ALSO REPORTED. UPDATE REC¿D 05/08/2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PSEUDOTUMORS THAT WERE PRESENT IN THE HIP WERE MOST LIKELY AN ADVERSE TISSUE REACTION TO THE METAL ON METAL HIP. DOI: (B)(6) 2010 - DOR: (B)(6) 2014 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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. 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 TO ADDRESS PSEUDOTUMORS. INFECTION WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249420 12/14 ARTICUL 40MM M SPEC+5 HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US 3072103

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention