BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED HIP HEAD

    MDR report key: 3895031 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21972
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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 COMPLAINT STATES THAT A REVISION OF A DUROLOC LINER WAS PERFORMED DUE TO DISLOCATION. NO MEDICAL RECORDS OR FURTHER INFORMATION WAS RECEIVED TO CONFIRM THIS. A PHOTO WAS PROVIDED OF THE EXPLANTS, HOWEVER NO LOT NUMBERS COULD BE IDENTIFIED. NOTIFICATION WAS RECEIVED STATING THAT NO FURTHER INFORMATION OR RETURN OF PRODUCTS IS AVAILABLE. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT OR PRODUCT NUMBERS WERE RECEIVED. 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. 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 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

    REVISION OF DUROLOC LINER: PERFORMED ON (B)(6) 2014 AT WHANGAREI HOSPITAL BY MR COUP. REASON FOR REVISION: DISLOCATION. PRIMARY: HIP REPLACEMENT PERFORMED IN 1996 AT WHANGAREI HOSPITAL BY MR COUP. NO PRODUCT CODES OR LOT NUMBERS AVAILABLE. 1 X 56 CUP AND 1 X 28MM LINER (LIPPED LINER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371533 UNIDENTIFIED HIP HEAD HIP FEMORAL HEAD KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention