BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14

    MDR report key: 6916668 · Received October 5, 2017

    Report

    Report Number
    0009613350-2017-01373
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    November 2, 2004
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK042249
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ZIMMER (B)(4) METASUL®, ALPHA INSERT, II/28, ITEM#01.00010.409, LOT#2212386. ZIMMER (B)(4): ALLOFIT ALLOCLASSIC SHELL 52/I I, ITEM#4245, LOT#22214665. ZIMMER INC.: METASUL HEAD 28/+4. THE DEVICE IS MANUFACTURED BY ZIMMER INC, (B)(4) AND WILL BE REPORTED UNDER (B)(4). THE REPORT NUMBER IS CURRENTLY UNKNOWN AS THE REPORT IS NOT YET SUBMITTED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO INFECTION. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER): EVENT SUMMARY: PATIENT RECEIVED THE PRIMARY THA (ALLOFIT SHELL 52/II, METASUL ALPHA INSERT II/28, METASUL HEAD 28/+4 ((B)(4) DESIGN, (B)(4)), CLS STEM 135) FOR LEFT HIP ON (B)(6) 2004 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2004 DUE TO INFECTION. ALL THE IMPLANTS WERE REVISED EXCEPT THE STEM. REVIEW OF RECEIVED DATA PRIMARY IMPLANTATION SURGERY NOTES DATED (B)(6) 2004: PRODUCTS IMPLANTED: ALLOFIT SHELL 52/II, METASUL ALPHA INSERT II/28, METASUL HEAD 28/+4 ((B)(4) DESIGN, (B)(4)), CLS STEM 135. NO SUSPICIOUS EVENTS OBSERVED DURING THE SURGERY THAT MIGHT HAVE LED TO THE INFECTION. REVISION SURGERY NOTES DATED (B)(6) 2004: ONE-STAGE REVISION OF LEFT THA DUE TO INFECTION. PRODUCTS REMOVED: ALLOFIT SHELL 52/II, METASUL ALPHA INSERT II/28, METASUL HEAD 28/+4. THE CLS STEM 135 WAS EXPLANTED, STERILIZED, AND RE-IMPLANTED. NEW PRODUCTS IMPLANTED: ALLOFIT SHELL 54/JJ, METASUL ALPHA INSERT JJ/28, METASUL HEAD 28/+4 ((B)(4) DESIGN, (B)(4)). TISSUE SAMPLES WERE SENT FOR EXAMINATION. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET STERILIZATION CERTIFICATES OF THE IMPLANTS WERE REVIEWED AND CONFIRMED TO BE CONFORMING TO THE RESPECTIVE STERILIZATION SPECIFICATIONS. CONCLUSION SUMMARY: FOR THE INVESTIGATION OF THE CASE SURGICAL REPORTS WITH THE IMPLANT STICKERS WERE RECEIVED. THE REVISION SURGERY REPORT DATED (B)(6) 2004 CONFIRMS THE EVENT OF INFECTION. ALL THE COMPONENTS EXCEPT THE STEM WERE REVISED. THE CLS STEM WAS REMOVED DURING THE SURGERY, CLEANED&RE-STERILIZED AND RE-IMPLANTED. STERILIZATION SPECIFICATIONS OF THE DEVICES CERTIFY THE SUITABILITY OF STERILIZATION. THE STERILIZATION CERTIFICATES ARE REVIEWED AND IT IS CONFIRMED THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS NOT SUSPECTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. POSSIBLE REASONS FOR THE INFECTION INCLUDE CONTAMINATION OF THE IMPLANTS DURING THE PRIMARY SURGERY, SECONDARY INFECTION, COMORBIDITY (PATIENT HAVING AN INFECTION IN ANOTHER SITE OF THE BODY), REUSE OF SINGLE USE COMPONENTS AND FAIL OF RESTERILIZATION METHOD AS SUGGESTED IN IFU. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT:0009613350-2017-01371, 0009613350-2017-01370.

    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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (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, 10.0, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2004 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2004 DUE TO INFECTION AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697658 CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14 CLS SPOTORNO STEM LZO ZIMMER GMBH N/A 2218074

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R