BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX60OD

    MDR report key: 4093252 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28200
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    1ST REVISION: RIGHT HIP PERFORMED ON (B)(6) 14 AT (B)(6). REASON: RECURRENCE OF DISLOCATION. PATIENT WAS REVISED POLYLINER AND LONGER +5 HEAD OPTION. PATIENT STABLE ON TABLE. PRIMARY: TOTAL HIP REPLACEMENT PERFORMED ON (B)(6) 2009 BY SAME DOCTOR AND AT SAME HOSPITAL. PT DETAILS: (B)(6). MALE. ALL EXPLANT CODES TO BE FORWARDED. PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571119 PINN MAR +4 10D 36IDX60OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 C4FDJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention