BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECTINJECT ON DEMAND HA CEMENT

    MDR report key: 8632041 · Received May 22, 2019

    Report

    Report Number
    0008010177-2019-00020
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 8, 2019
    Report Date
    August 1, 2019
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    GXP
    UDI-DI
    07613327123265
    PMA / PMN Number
    K143661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE INFORMATION PROVIDED WAS NOT SUFFICIENT. IN ORDER TO OBTAIN MORE DETAILS ABOUT THE REPORTED EVENT AND DETERMINE A COMPLAINT ROOT CAUSE, THE ¿INFECTION COMPLAINTS ¿ CHECKLIST CUSTOMER¿ (CMFQF 13-003) WAS FORWARDED TO THE SALES REP. HOWEVER, IT WAS STATED THAT NO FURTHER INFORMATION CAN BE PROVIDED. FOR INFECTION COMPLAINTS EXPANDED INVESTIGATIONS ARE PERFORMED AT THE MANUFACTURING SITE, STRYKER ORTHOPAEDICS, IN LIMERICK (IRELAND) TO ASSURE THAT NEITHER THE COMPLAINED DEVICE NOR ALL RELATED MANUFACTURING PROCESS STEPS HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, IT IS EVALUATED IF THE RISK ASSUMPTIONS IN THE RELATED FMEA ARE IN CORRESPONDENCE WITH THE REPORTED EVENT. IN THIS CASE NO LOT NUMBER WAS PROVIDED. THEREFORE, IT IS CONSIDERED TO BE APPROPRIATE TO REFERENCE A CHECKLIST THAT WAS COMPLETED FOR A FORMER INFECTION COMPLAINT IN WHICH ALSO NO LOT NUMBER WAS REPORTED AND THE SAME CATALOG NUMBER WAS INVOLVED (PI 2081849). WITHIN THAT EXPANDED INVESTIGATION NO DISCREPANCIES WERE DOCUMENTED WITHIN THE CORRESPONDING ¿INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿ (CMFQF 13-002). SUMMARIZING ALL OBTAINED INFORMATION, THE COMPLAINT ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE INFORMATION PROVIDED WAS NOT SUFFICIENT. BASED ON THE INVESTIGATION INCLUDING A STATISTICAL ANALYSIS, AS WELL AS, BASED ON THE RESULTS OF THE EXPANDED INVESTIGATION AT THE MANUFACTURING SITE THERE IS NO INDICATION THAT THE PRODUCT IS NOT WORKING AS INTENDED OR ANY SYSTEMATIC DESIGN, MATERIAL, OR MANUFACTURING RELATED ISSUE EXISTS. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A COMPANY REPRESENTATIVE THAT AN INFECTION OCCURRED WITH A PATIENT AFTER A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THERE ARE NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME, AND DEVICE "RELATIVITY"/INVOLVEMENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATED BY MFR: DEVICE IS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A COMPANY REPRESENTATIVE THAT AN INFECTION OCCURRED WITH A PATIENT AFTER A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THERE ARE NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME, AND DEVICE "RELATIVITY"/INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426803 DIRECTINJECT ON DEMAND HA CEMENT IMPLANT GXP STRYKER LEIBINGER FREIBURG UNK 07613327123265

    Patients

    Seq Age Sex Outcome Treatment
    1