BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 4 10MM

    MDR report key: 3140437 · Received May 31, 2013

    Report

    Report Number
    1818910-2013-17966
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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

    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. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH B)(4) APPENDIX A; REV. PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED INPUTS CONFIRMED THE REPORTED INFECTION. IT IS LIKELY A RASH BECAME OPEN AND EXCORIATED IN THE AREA OF THE PREVIOUS INCISION AND EVENTUAL DEVELOPMENT OF A BLISTER THAT BECAME INFECTED AND TRACKED TO THE JOINT IS RELATED TO THE INFECTION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND 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

    THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241704 SIGMA STAB XLK INS 4 10MM TIBIAL INSERT JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention