BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY RECLAIM 24X85 PROXIMAL BODY

    MDR report key: 3080757 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-16132
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED ON (B)(6) 2013 (REPORTED SEPARATELY) DUE TO A CORAIL STEM THAT WAS UNDERSIZED AND LOOSE. THE PATIENT STATED THAT IT IS DIFFICULT TO WALK ON HIS NEW IMPLANT AND HE CAN FEEL HIS GREATER TROCH THROUGH THE SKIN. THE PATIENT IS DEMANDING THE STEM BE REMOVED. X RAYS AND BONE SCAN BOTH CAME BACK WITH NORMAL RESULTS. SURGEON ADVISED PATIENT AND HIS FAMILY AGAINST REVISION AND ORDERED A PSYCHIATRIC EVALUATION ON PATIENT, WHO IS HIV-POSITIVE. DUE TO THE PATIENT AND FAMILY'S PERSISTENT REQUEST, THE PATIENT WAS REVISED. DOI (B)(6) 2013 - DOR (B)(6) 2013 (RIGHT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON (B)(6) 2013 (REPORTED SEPARATELY) DUE TO A CORAIL STEM THAT WAS UNDERSIZED AND LOOSE. THE PATIENT STATED THAT IT IS DIFFICULT TO WALK ON HIS NEW IMPLANT AND HE CAN FEEL HIS GREATER TROCH THROUGH THE SKIN. THE PATIENT IS DEMANDING THE STEM BE REMOVED. X-RAYS AND BONE SCAN BOTH CAME BACK WITH NORMAL RESULTS. SURGEON ADVISED PATIENT AND HIS FAMILY AGAINST REVISION AND ORDERED A PSYCHIATRIC EVALUATION ON PATIENT, WHO IS (B)(6). DUE TO THE PATIENT AND FAMILY'S PERSISTENT REQUEST, THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181113 UNKNOWN DEPUY RECLAIM 24X85 PROXIMAL BODY HIP PROSTHESIS KWY 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention