BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR BANTAM 10D 22.225X42 LINER

    MDR report key: 3925316 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23093
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 24, 2013
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    ADDITIONAL NARRATIVE: 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 WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. 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

    CLINCIAL REPORT RECEIVED. REPORT INDICATES PATIENT SUFFERED FROM OSTEOLYSIS AND POLY WEAR. PART AND LOT INFORMATION, AS WELL AS THE IMPLANT DATE HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    FDA ORTHOPAEDIC DEVICE EXEMPTION DETERMINATION REQUEST CHECKLIST STATES THAT HIS PATIENT HAS BEEN DIAGNOSED WITH OSTEOLYSIS, BUT HAS NOT BEEN REVISED BECAUSE THE HE IS HESITANT TO IMPLANT ANOTHER ENDURON LINER, WHICH HE STATES IS THE ONLY LINER MATERIAL AVAILABLE FOR THE PATIENT'S BANTAM CUP. HE WAS INQUIRING ABOUT THE POSSIBILITY OF HAVING A CUSTOM LINER CREATED OUT OF ALTRX. UPDATE RECEIVED (B)(6) 2014. THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS POLY WEAR. THIS COMPLAINT WAS UPDATED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403073 DUR BANTAM 10D 22.225X42 LINER HIP ACETABULAR INSERT/LINER HRY DEPUY ORTHOPAEDICS, INC.-1818910 397190002

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention