BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED CUP

    MDR report key: 3964829 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24370
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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

    ADDITIONAL NARRATIVE: THE COMPLAINT STATES THAT INITIAL THA WAS CONDUCTED ON (B)(6) 2011 AND THE PATIENT SUFFERED FROM RECURRENT DISLOCATIONS. IT WAS NOTED THAT THE CUP WAS IMPLANTED AT AN ANGLE OF 55 DEGREES WHICH MIGHT BE THE CAUSE OF THE DISLOCATIONS. REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2014. NO FURTHER INFORMATION WAS RECEIVED. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. 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 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

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    THE INITIAL THA WAS CONDUCTED ON (B)(6) 2011. AFTER A WHILE, THE PATIENT HAS SUFFERED THE DISLOCATION OF THE HIP JOINT ON NUMEROUS OCCASIONS. WHEN HE WAS EXAMINED, IT WAS FOUND THAT THE CUP WAS IMPLANTED AT THE ANGLE OF 55 DEGREES, AND DIAGNOSED THAT THIS COULD BE THE CAUSE OF THE DISLOCATIONS. THEREFORE, THE REVISION WAS CONDUCTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441862 UNIDENTIFIED CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention