BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKONWN DEPUY BROACH

    MDR report key: 3833874 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-18808
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT SUSTAINED AN INSERTIONAL CRACK FROM THE BROACH. THE FEMORAL STEM IS BEING CHANGED TO AN UNKNOWN BROACH. THE CRACK WAS TREATED WITH CABLES PRIOR TO INSERTING THE FEMORAL STEM. THE INVESTIGATION IS ONGOING. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THIS MEDWATCH WAS SUBMITTED ON TIME ON (B)(4) 2014. DUE TO OUTAGES ON THE FDA'S RECEIVING SIDE, WE ARE RESUBMITTING THIS MEDWATCH AT THE FDA'S REQUEST.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: CLINICAL REPORT STATES THAT THE PATIENT SUFFERED A FEMUR FRACTURE INTRA-OPERATIVELY. UPDATE REC¿D 05/22/2014- PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT SUSTAINED AN INSERTIONAL CRACK FROM THE BROACH. THE FEMORAL STEM IS BEING CHANGED TO AN UNKNOWN BROACH. THE CRACK WAS TREATED WITH CABLES PRIOR TO INSERTING THE FEMORAL STEM. DOI: (B)(6) 2014 (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. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT THE PATIENT SUFFERED A FEMUR FRACTURE INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310864 UNKONWN DEPUY BROACH HIP OTHER IMPLANT KWY DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention