BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 NEUT 32IDX56OD

    MDR report key: 3920299 · Received July 8, 2014

    Report

    Report Number
    1818910-2014-22956
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. COMPLAINT TO PART (B)(4), DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: ¿NON DEPUY PRODUCT¿ 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.

    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 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 AND IS CONSIDERED OFF LABEL USE. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397070 PINN MAR +4 NEUT 32IDX56OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 D2AH61000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention