BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIDENTIFIED STEM

    MDR report key: 3973575 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24823
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THE REVISION DUE TO RECURRENT DISLOCATIONS AND CORROSION ON THE NECK AND HEAD. NO MEDICAL RECORDS OR RETURN OF PARTS WERE RECEIVED TO CONFIRM THIS. NOTIFICATION WAS RECEIVED STATING THAT NO FURTHER INFORMATION OR RETURN OF PRODUCTS IS AVAILABLE. A COMPLAINTS DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT NUMBERS WERE PROVIDED. 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 SEP 419. 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

    THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO THE RECURRENT DISLOCATION.DATE OF THE INITIAL THA SURGERY IS UNKNOWN.DURING THE SURGERY THE SURGEON IDENTIFIED SLIGHT CORROSION ON THE NECK AND THE HEAD. THE IMPLANTS WERE REPLACED WITH A DURALOC 28MM LINER AND A DELTA 28MM HEAD.THE SURGEON BELIEVES THAT THE SHAPE OF THE AML NECK COULD HAVE CAUSED THE DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451088 UNIDENTIFIED STEM HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other