BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA*FEM STEM, M SERIES,SZ2M

    MDR report key: 2920519 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11128
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    August 8, 2005
    Report Date
    January 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWL
    PMA / PMN Number
    PK900638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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.

    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. DURING REVIEW OF MEDICAL RECORDS RECEIVED BY THE LEGAL DEPARTMENT, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED DUE FEMORAL LOOSENING. POLY WEAR WAS NOTED INTRAOPERATIVELY. DOI: (B)(6) 2003 - DOR: (B)(6) 2005 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE STEM'S PROVIDED PRODUCT/LOT COMBINATION DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE LINER AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE PATIENT IS A REPORTED FEMALE, BORN (B)(6), WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    DURING REVIEW OF MEDICAL RECORDS RECEIVED BY THE LEGAL DEPARTMENT, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED DUE FEMORAL LOOSENING. POLY WEAR WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25581 ULTIMA*FEM STEM, M SERIES,SZ2M FEMORAL STEM KWL DEPUY ORTHOPAEDICS, INC. 665214

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention