BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE MODULAR HD 26MM +0

    MDR report key: 6295716 · Received February 2, 2017

    Report

    Report Number
    1818910-2017-11790
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 11, 2017
    Report Date
    January 11, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    K871867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). 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 COMPLAINT STATES THE PATIENT REPEATED DISLOCATION. SO, THE DOCTOR REPLACED THE REPORTED LINER(1240-52-000,LOT UNKNOWN) AND HEAD(9625-70-000,LOT UNKNOWN).THE DOCTOR DIDN¿T PLAN TO EXCHANGE IMPLANTED STEM. BUT, THE DOCTOR REPLACED THE REPORTED STEM(1522-04-000,LOT UNKNOWN) FOR THE PURPOSE OF GETTING OFFSET. A COMPLAINTS SEARCH AND REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO PRODUCT DETAILS WERE RECEIVED. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER (B)(4). 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.

    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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS REPEATED DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80733 ELITE MODULAR HD 26MM +0 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 1193149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention