BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER NEUTRAL BOLT

    MDR report key: 2992965 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13396
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK060515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS REPORTED AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION; ONE ADDITIONAL REPORT FOR THE SIGMA FEM ADAPTER PART AND LOT NUMBER COMBINATION BUT FOR LOOSENING. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. PROVIDED INFORMATION STATES PATIENT WAS TESTED AND FOUND TO BE ALLERGIC TO COBALT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ALLERGY TO COBALT, WHICH CAUSED SWELLING, PAIN, AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98236 SIGMA FEM ADAPTER NEUTRAL BOLT FEMORAL KNEE PROSTHESIS JWH 1818910 DEPUY ORTHOPAEDICS, INC. BN3HJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention