BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, STEM, 135, UNCEMENTED, 16.25, TAPER 12/14

    MDR report key: 6844245 · Received September 6, 2017

    Report

    Report Number
    0009613350-2017-01193
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 14, 2015
    Report Date
    February 9, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: ITEM: NEUTRAL NECK USE WITH 12/14 TAPER STEMS ONLY 28 CATALOG #: 7340-28-000 LOT #: 1440815 ITEM: ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL CATALOG #: 4248 LOT #: 2276245 ITEM: METASUL, ALPHA INSERT, HOODED, LL/28 CATALOG #: 01.00010.512 LOT #: 2242077.. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION, FLUID COLLECTION AND ARMD. EVENT DESCRIPTION: PRODUCT WAS IMPLANTED ON (B)(6) 2005 AND REVISED ON (B)(6) 2015 DUE FLUID COLLECTION, INFECTION AND ARMD. REVIEW OF RECEIVED DATA: THE IMPLANTATION REPORT DATED (B)(6) 2005 AND THE REVISION REPORT DATED (B)(6) 2015 ARE AVAILABLE (RIGHT SIDE). THE REPORTS ARE IN FRENCH. NO SPECIFIC INFORMATION AVAILABLE IN THE IMPLANTATION REPORT. THE REVISION REPORT DESCRIBES THAT THE PATIENT WAS REVISED DUE TO INFECTION AND ARMD. NO OTHER RELEVANT INFORMATION FOR THE INVESTIGATION. THERE ARE FURTHER REPORTS AVAILABLE WHICH ARE EITHER FOR THE LEFT SIDE OR REPORTS AFTER THE REVISION SURGERY DONE ON (B)(6) 2015. NO OTHER RELEVANT INFORMATION IN THE LEGAL DOCUMENT. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ALL POSSIBLE CAUSES RELATED TO INFECTION ARE CONSIDERED IN DFMEA. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2005 AND REVISED ON (B)(6) 2015 DUE INFECTION AND ARMD. THE DEVICES WERE 10 YEARS IN VIVO. THIS COMPLAINT IS ABOUT THE RIGHT SIDE. THE LEFT SIDE IS REGARDING A DUROM WHICH IS TREATED IN COMPLAINT (B)(4). THE DEVICES HAVE NOT BEEN RETURNED FOR THE INVESTIGATION. THEREFORE, NO ANALYSIS OF THE DEVICES COULD BE DONE. NO X-RAYS HAVE BEEN RECEIVED. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICES CERTIFIED THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A CLS SPOTORNO, STEM, 135, UNCEMENTED, 16.25, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2005 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO FLUID COLLECTION, INFECTION AND ARMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627091 CLS SPOTORNO, STEM, 135, UNCEMENTED, 16.25, TAPER 12/14 CLS SPOTORNO STEM LZO ZIMMER GMBH N/A 2260670

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R