BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 5, TAPER 12/14

    MDR report key: 7458509 · Received April 25, 2018

    Report

    Report Number
    0009613350-2018-00469
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    January 26, 2016
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AROUND 10 MONTHS POST IMPLANTATION DUE TO INFECTION OF THE HIP. NOTE: THIS IS A SPLIT CASE (B)(4) FOR THE ALLOCLASSIC VARIALL BIOLOX DELTA LINER AS THE DESIGN OWNER OF THIS DEVICE IS ZIMMER BIOMET INC., WARSAW. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED IT WAS DISCARDED AT THE HOSPITAL. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM (B)(6) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. -IFU D011500211 (FOR ALLOCALSSIC SL STEM) ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW (FOR STEM): - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH THE CLEANING PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH THE STERILIZATION PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH THE PACKAGING WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION => POSSIBLE, THE HANDLING AND STORAGE OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE STERILIZATION PROCEDURE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH STERILIZATION PROCEDURE WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - CHEMICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE CLEANING PROCEDURE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH CLEANING PROCEDURE WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY NOT POSSIBLE -> THE IFU D011500211 DESCRIBES IN CHAPTER "WARNINGS" HOW TO PROCEED WITH THE DEVICE: "IMPLANTS ARE FOR SINGLE USE ONLY. REUSE OF A SINGLE USE DEVICE THAT HAS COME IN CONTACT 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.". NO INFORMATION RECEIVED, THAT AN EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY. THEREFORE, THIS CAUSE CAN BE EXCLUDED. CONCLUSION SUMMARY IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AROUND 10 MONTHS POST IMPLANTATION DUE TO INFECTION. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES 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. AS NO LOT NUMBER WAS PROVIDED FOR THE VARIAL SHELL, THE DEVICE HISTORY RECORDS AND ITS ASSOCIATED STERILIZATION CERTIFICATE COULD NOT BE REVIEWED. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR AND SUITABLE STERILIZATION CERTIFICATES. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THOSE PRODUCTS. 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. IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVOURED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE APPROPRIATE IFUS FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. NEVERTHELESS, POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: BIOLOX DELTA, CERAMIC FEMORAL HEAD, ITEM#: 00-87750-32-03, LOT#: 2791330; ITEM: ALLOCLASSIC VARIALL, SHELL WITH POLAR SCREW, ITEM#: 01.00044.011, LOT#: UNKNOWN; ITEM: ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, KK/32, ITEM#: 00877401232, LOT#: 2775846. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2018 TO THE APPROPRIATE REPRESENTATIVES. THE NAME OF THE DEVICE; ANY DEVICE IDENTIFICATION(S) AND CONTROL NUMBER(S) USED (REF; LOT); THE NAME, ADDRESS, AND PHONE NUMBER OF THE COMPLAINANT; THE AVAILABILITY OF THE AFFECTED PRODUCT(S) (NON-AVAILABILITY WITH A RATIONALE); EXACT EVENT DATE; IMPLANT DATE; EXPLANT DATE; IMPLANTATION REPORT; REVISION REPORT; ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE; ALL AVAILABLE INTRAOPERATIVE PICTURES; PATIENT DOB, WEIGHT, HEIGHT, BMI AND ALL RELEVANT HISTORY; WAS THIS MEDICAL INTERVENTION FOR CORRECTION OF AN INFECTION? IF YES, EXPLAIN. HAS AN INFECTION OCCURRED WITHIN ONE YEAR POST OPERATIVELY? DOES THE AVAILABLE INFORMATION SUGGEST THE DEVICE/PRODUCT HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED? IF YES, EXPLAIN CIRCUMSTANCE. DID A DELAY IN THE PROCEDURE OVER 30 MINUTES OCCUR THAT WAS RELATED TO THE EVENT? TIME SURGERY WAS EXTENDED WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NON-COMPLIANCE, PATIENT ANATOMY) WAS THE SURGICAL TECHNIQUE FOR THE PRODUCT UTILIZED? 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. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00404 -1, 0009613350 -2018 -00407 - 1. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(6) REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY AND UNDERWENT SUBSEQUENTLY TO REVISION SURGERY DUE TO INFECTION. THE REVISION TOOK PLACE APPROXIMATELY 10 MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306038 ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 5, TAPER 12/14 N/A KWA ZIMMER GMBH N/A 2791963

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R