BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SROM FEMORAL STEM

    MDR report key: 4130015 · Received September 30, 2014

    Report

    Report Number
    1818910-2014-29126
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNAVAILABLE. 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

    (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.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

    THE DEVICES ASSOCIATED WITH THIS COMPLAINT WERE NOT RETURNED. A WORLDWIDE COMPLAINT DATABASE SEARCH COULD NOT BE COMPLETED FOR THE FEMORAL SLEEVE AND FEMORAL STEM AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. X-RAY(S) WERE OBTAINED AND REVIEWED; CONFIRMING THE REPORTED IMPLANT FRACTURE AFTER THE PATIENT FELL. 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 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

    PATIENT WAS REVISED DUE TO A STEM FRACTURE AS THE RESULT OF A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609352 UNKNOWN DEPUY SROM FEMORAL STEM HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND 9616671 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention