BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M 32/0, TAPER 12/14

    MDR report key: 7398712 · Received April 5, 2018

    Report

    Report Number
    0009613350-2018-00421
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 8, 2018
    Report Date
    September 26, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF REPORT, DATE REC¿D BY MFR, PMA/510K. DEVICE HISTORY RECORDS (DHR): 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. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH BIOLOX - KINECTIV NECK ON (B)(6) 2018 AND UNDERWENT REVISION ON MARCH 8, 2018 DUE TO INFECTION. THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAWREFERENCE NUMBER: (B)(4) (MFR 0001822565-2018-01805). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE RECEIVED INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW : NON-STERILE 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. MOREOVER, THE STERILIZATION CERTIFICATE FOR THIS LOT HAS BEEN REVIEWED AND CONFIRMED THAT THE IMPLANT HAS BEEN STERILIZED ACCORDING TO SPECIFICATIONS. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE NOT POSSIBLE A SYSTEMATIC ISSUE WITH THE PACKAGING DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT . NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER THE INFORMATION GIVEN IN THE PACKAGING INSERT IFU D011500245 CHAPTER "RESTERILIZATION INFORMATION" HAS BEEN FOLLOWED. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM . POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER THE INFORMATION GIVEN IN THE PACKAGING INSERT IFU D011500245 CHAPTER "WARNINGS" HAS BEEN FOLLOWED. NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE POSSIBLE, THE HANDLING AND STORAGE OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT (E.G. USE OF EXPIRED PRODUCT, RESTERILIZATION OF HEAD) NOT POSSIBLE. A SYSTEMATIC ISSUE WITH THE INADEQUATE LABELLING WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION LESS THAN ONE MONTH AFTER IMPLANTATION. 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. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PRODUCT FAMILY. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THIS PART OR LOT NUMBER. NEVERTHELESS, AN INFECTION CAN HAVE NUMEROUS ROOT CAUSES. 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LINER NEUTRAL 32 MM I.D. SIZE I I FOR USE WITH 52 MM O.D. SIZE II SHELL CATALOG #:00875101032 ; LOT #: 63292541, SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS CATALOG #: 00875705201 ; LOT #: 63655133. MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED WITH CALCICOAT CERAMIC COATING CEMENTLESS SIZE 12.5 CATALOG #: 65771301200; LOT #: 63274596. THERAPY DATE: (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. 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

    PRODUCT WAS IMPLANTED ON LEFT SIDE AND PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242063 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M 32/0, TAPER 12/14 BIOLOX DELTA, CERAMIC FEMORAL HEAD, LZO ZIMMER GMBH N/A 2923921

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R