BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZT HA 18F-XXL

    MDR report key: 3962944 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24324
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    MEH
    PMA / PMN Number
    PK912713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PROCEDURE: REVISION RIGHT HIP. ORIGINAL OPERATION DATE (B)(6) 1999 PERFORMED BY DR (B)(6) AT (B)(6) HOSPITAL. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 AT (B)(6) UNIVERSITY HOSPITAL. REASON FOR REVISION: ASEPTIC LOOSENING. X-RAY PHOTOS ARE AVAILABLE. NO FURTHER NOTES AVAILABLE. ON (B)(6) 2014 - THE FEMORAL COMPONENTS WERE THE ONLY COMPONENTS REVISED, THEREFORE IT WAS THE STEM THAT WAS LOOSE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. X-RAYS WERE OBTAINED AND REVIEWED BY ENGINEERING. 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

    PROCEDURE: REVISION RIGHT HIP. ORIGINAL OPERATION DATE (B)(6) 1999 PERFORMED BY DR (B)(6) AT THE (B)(6) . REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 AT (B)(6). REASON FOR REVISION: ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442032 S-ROM*SLEEVE PRX ZT HA 18F-XXL HIP FEMORAL STEM/SLEEVE MEH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC SB101628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention