BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 58MM GRIPTION SOCKET

    MDR report key: 3050836 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-15181
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    May 15, 2012
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. BASED ON THE INFORMATION MADE AVAILABLE WITHIN THE REVISION OPERATIVE NOTE THE COMPLAINT IS NOT PRODUCT RELATED, BUT APPEARS TO BE RELATED TO THE PREVIOUS SURGICAL TECHNIQUE AND PLACEMENT OF THE COMPONENTS. THE INVESTIGATION COULD NOT DRAW ANY FURTHER CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT'S OPERATIVE RECORDS INDICATE THE PATIENT THE PATIENT WAS REVISED TO ADDRESS AN UNSTABLE HIP THAT WAS SUBLUXING AND DISLOCATED AND BECOMING PAINFUL. UPON REVISION IT WAS NOTED THE FEMORAL NECK WOULD IMPINGE ON THE HETEROTOPIC BONE IN THE POSTERIOR SOFT TISSUES AND ELEVATE OUT OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149875 UNKNOWN DEPUY 58MM GRIPTION SOCKET CUP JDI DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention