BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROSTALAC STEM

    MDR report key: 3853918 · Received June 6, 2014

    Report

    Report Number
    1818910-2014-20409
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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. 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

    PATIENT WAS REVISED DUE TO A BROKEN TIP FROM A PROSTALAC STEM. PATIENT WAS IMPLANT WITH THE PROSTALAC COMPONENTS IN (B)(6) 2014. PARTS WERE THEN REMOVED ON (B)(6) 2014. POST OP REVEALED THAT A PIECE OF THE PROSTALAC STEM HAD BROKEN OFF AND LEFT IN THE PATIENT. THE PIECE WAS THEN REMOVED ON (B)(6) 2014. DOI: (B)(6) 2014 - DOR: (B)(6) 2014 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. 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

    PATIENT WAS REVISED DUE TO A BROKEN TIP FROM A PROSTALAC STEM. PATIENT WAS IMPLANT WITH THE PROSTALAC COMPONENTS IN (B)(6) 2014. PARTS WERE THEN REMOVED ON (B)(6) 2014. POST OP REVEALED THAT A PIECE OF THE PROSTALAC STEM HAD BROKEN OFF AND LEFT IN THE PATIENT. THE PIECE WAS THEN REMOVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332686 UNKNOWN PROSTALAC STEM HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention