BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ2 HI OFF

    MDR report key: 2992038 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13291
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE PATIENT WAS REVISED BECAUSE OF A FRACTURED FEMUR AROUND THE IMPLANT. IT WAS NOTED THAT THE PATIENT FELL. DOI: (B)(6) 2013, DOR: (B)(6) 2013. 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 SINCE ITS RELEASE FOR DISTRIBUTION. TWO X-RAY IMAGES WERE RECEIVED WITH THE INITIAL REPORTING CONFIRMING THE BONE FRACTURE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). NO ADDITIONAL INFORMATION WAS OBTAINED. THE PATIENT FALL / TRAUMA IS SUSPECTED AS THE ROOT CAUSE. BASED ON THE INVESTIGATION, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF A FRACTURED FEMUR AROUND THE IMPLANT. IT WAS NOTED THAT THE PATIENT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97835 SUMMIT POR TAPER SZ2 HI OFF HIP REPLACEMENT LPH 1818910 DEPUY ORTHOPAEDICS, INC. 306311

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention