BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7352367 · Received March 20, 2018

    Report

    Report Number
    0009613350-2018-00365
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    December 16, 2009
    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 · 1

    CONCOMITANT MEDICAL PRODUCTS: ALLOFIT ALLOCLASSIC SHL 54/JJ, REF#4246, LOT#2220028. METASUL, ALPHA INSERT, JJ/28, REF# 01.00010.410, LOT# 2187237. METASUL COCR FEM HD SAMPL E, REF#734028400S , LOT#1597498. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TEND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO INFECTION. REVIEW OF EVENT DESCRIPTION: THE PATIENT RECEIVED NEW IMPLANTS (ALLOFIT SHELL 54/JJ, METASUL ALPHA INSERT JJ/28 AND METASUL HEAD 28/+4 FOR LEFT HIP ON (B)(6) 2004 DURING THE REVISION SURGERY DUE TO INFECTION AND UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2009 DUE TO INFECTION. METASUL SHELL WAS KEPT IN, WHILE THE OTHER COMPONENTS WERE REPLACED WITH DEPUY IMPLANTS (AS THE FIRST STAGE OF THE REVISION). 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 (ZIMMER INC., (B)(4) DESIGN), CLS STEM 135. NO SUSPICIOUS EVENTS OBSERVED DURING THE SURGERY THAT MIGHT HAVE LED TO THE INFECTION. 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 (ZIMMER INC., (B)(4) DESIGN). TISSUE SAMPLES WERE SENT FOR EXAMINATION. REVISION SURGERY NOTES DATED (B)(6) 2009: FIRST STAGE OF THE REVISION DUE TO SUSPECTED INFECTION AND IMPLANTATION OF PROSTALAC PROSTHESIS (FUNCTIONAL SHORT TERM REPLACEMENT FOR PATIENTS WHO NEED A TWO-STAGE PROCEDURE TO TREAT INFECTION). THE STEM CLS STEM 135 WAS FOUND LOOSE AND WAS REMOVED. THE ALLOFIT SHELL 54/JJ WAS STABLE AND IT WAS DECIDED TO KEEP IT IMPLANTED FOR THE MOMENT. THE METASUL ALPHA INSERT JJ/28 WAS REMOVED, THE CUP WAS WASHED AND THE NEW POLYETHYLENE (PROSTALAC ACETABULAR CUP FROM DEPUY) WAS CEMENTED INSIDE THE CUP. A PROSTALAC STEM (DEPUY) WAS IMPLANTED. FEMORAL HEAD FROM DEPUY IMPLANTED. REVISION SURGERY ON (B)(6) 2010 DUE TO ORTHOSTASIS AFTER IMPLANTATION OF PROSTALAC PROSTHESIS (SECOND STAGE OF THE REVISION DUE TO INFECTION). CONVERSION TO TOTAL HIP PROSTHESIS. NO SIGNS OF INFECTION, NO TISSUE NECROSIS. REMOVAL OF ALL COMPONENTS. IMPLANTATION OF CONVERGE CUP, EPSILON DURASUL INSERT, REVITAN STEM, COCR HEAD . PRODUCT STICKERS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, 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: ACCORDING AVAILABLE INFORMATION AT THE HAND PATIENT UNDERWENT REVISION SURGERY AFTER 5 YEARS 1 MONTH DUE TO INFECTION. FOR THE INVESTIGATION OF THE CASE, SURGICAL REPORTS WITH THE IMPLANT STICKERS WERE RECEIVED. THE REVISION SURGERY REPORT DATED (B)(6) 2009 CONFIRMS THE EVENT OF INFECTION. SURGEON REVISED ALL THE ZIMMER IMPLANTS EXCEPT THE ALLOFIT SHELL. CLS STEM WAS FOUND TO BE LOOSE TOO. PROSTALAC PROSTHESIS COMPONENTS (MANUFACTURED BY DEPUY) WERE PLACED IN ORDER FOR THE FIRST STAGE OF THE REVISION DUE TO INFECTION. DEPUY INSERT WAS CEMENTED ONTO THE ALLOFIT SHELL THAT WAS KEPT IN. 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. IT IS KNOWN THAT THE CLS STEM, WHICH WAS IMPLANTED ON (B)(6) 2004, WAS REMOVED DURING THE SURGERY ON (B)(6) 2004, CLEANED AND RE-STERILIZED AND THEN RE-IMPLANTED. IMPLANTS ARE FOR SINGLE USE ONLY AND REUSE OF A SINGLE USE DEVICE THAT HAS COME WITH BLOOD, BONE, TISSUE OR OTHER BODY FLUIDS MAY LEAD TO PATIENT OR USER INJURY. POSSIBLE RISKS ASSOCIATED WITH REUSE OF A SINGLE USE DEVICE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL FAILURE AND TRANSMISSION OF INFECTIOUS AGENTS. THEREFORE THE MOST LIKELY CAUSE OF THE INFECTION EVENT IS REUSE OF THE CLS STEM. POSSIBLE OTHER REASONS FOR THE INFECTION INCLUDE CONTAMINATION OF THE PRODUCTS DURING THE REVISION SURGERY, SECONDARY INFECTION, COMORBIDITY (PATIENT HAVING AN INFECTION IN ANOTHER SITE OF THE BODY) AND FAIL OF RESTERILIZATION METHOD AS SUGGESTED IN IFU. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT RECEIVED A THA ON THE LEFT SIDE (THIS WAS ALREADY A REVISION SURGERY) AND WAS REVISED FIVE YEARS LATER DUE TO INFECTION. DURING SURGERY, IT WAS SEEN THAT THE STEM WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198938 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 37 YR Hospitalization| R