BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLS STEM 145 9.0 12/14

    MDR report key: 4942087 · Received July 23, 2015

    Report

    Report Number
    9613350-2015-00829
    Event Type
    Other
    Date Received
    July 23, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. IT IS STATED IN THE LITIGATION THAT THE ZIMMER PRODUCT WAS USED WITH COMPETITORS' PRODUCTS. IT WAS REPORTED THAT THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF A ZIMMER HIP IMPLANT MIXED WITH A FINSBURY ADEPT ACETABULAR CUP AND HEAD FAILURE. LITIGATION LETTER CONFIRMS THAT THE ZIMMER PRODUCT WAS USED WITH COMPETITORS' PRODUCTS. THE CORRECT IMPLANTATION OF THE CLS STEMS IS DESCRIBED IN SURGICAL TECHNIQUE FOR ZIMMER CLS STEMS. IFU FOR CLS STEMS IS REVIEWED; IT STATES THAT "ONLY AUTHORIZED COMBINATIONS MUST BE USED. TO DETERMINE WHETHER THESE DEVICES HAVE BEEN AUTHORIZED FOR USE IN A PROPOSED COMBINATION, PLEASE CONTACT YOUR ZIMMER SALES REPRESENTATIVE OR VISIT THE ZIMMER WEBSITE: WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM." ACCORDING TO THE RECEIVED DOCUMENTATION A CLS STEM WAS COMBINED WITH FINSBURY DEVICES. THIS PRODUCT COMBINATION IS NOT AUTHORIZED BY ZIMMER BIOMET. THE IFU FOR CLS STEMS DOC. D011500211 VER. 03 IS STATES THAT "ONLY AUTHORIZED COMBINATIONS MUST BE USED. TO DETERMINE WHETHER THESE DEVICES HAVE BEEN AUTHORIZED FOR USE IN A PROPOSED COMBINATION, PLEASE CONTACT YOUR ZIMMER SALES REPRESENTATIVE OR VISIT THE ZIMMER WEBSITE: WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM." FOLLOWING, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. HOWEVER WE COULD IDENTIFY A ROOT CAUSE FOR THE ISSUE. CLS STEM WAS COMBINED WITH COMPETITORS' PRODUCTS. (CUP AND HEAD) THEREFORE, WE CONSIDER OFF-LABEL USE AS A ROOT CAUSE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A LEGAL CLAIM WAS RAISED. IT HAS BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A CLS STEM 145 9.0 12/14 MIXED WITH A FINSBURY ADEPT ACETABULAR CUP AND HEAD FAILURE APRIL 1, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479837 CLS STEM 145 9.0 12/14 ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH 2485399

    Patients

    Seq Age Sex Outcome Treatment
    1 Other