BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED CERAMIC HIP HEAD

    MDR report key: 4192482 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30403
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDG
    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. FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT OR PRODUCT NUMBERS WERE RECEIVED. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND MONITORED THOUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER (B)(4). 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 REPORT IS A DUPLICATE AND THE PART INFORMATION REVEALED THAT THE PRODUCT IS NOT SOLD IN THE US, THEREFORE THIS REPORT IS BEING REJECTED.

    Description of Event or Problem · 1

    PATIENT RECEIVED HIP-TEP IN ANOTHER HOSPITAL. REVISION IN ABOUT 2013 BECAUSE OF BREAKAGE OF CERAMIC HIP HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672218 UNIDENTIFIED CERAMIC HIP HEAD HIP FEMORAL HEAD JDG DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention