BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14

    MDR report key: 7381038 · Received March 29, 2018

    Report

    Report Number
    0009613350-2018-00408
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 29, 2016
    Report Date
    September 10, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: 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 UNDERWENT A REVISION SURGERY AROUND 15 DAYS POST IMPLANTATION DUE TO INFECTION OF THE HIP. ONLY HEAD AN LINER WERE REVISED, THE OTHER COMPONENTS OF THE HIP RESTED IN SITU. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4), MFR 0001822565-2018-01793(FOR ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT). 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 INFORMATION RECEIVED IT WAS DISCARDED AT THE HOSPITAL. 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 (FOR BIOLOX DELTA HEAD): - 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. THEREFORE, THIS CAUSE CAN BE EXCLUDED. - 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. THEREFORE, THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD => NOT POSSIBLE -> IFU D011500245 CHAPTER "RESTERILIZATION INFORMATION" BIOLOX DELTA CERAMIC FEMORAL HEADS MUST NOT BE RESTERILIZED BY ANY METHOD. NO INFORMATION RECEIVED, THAT THE SURGEON RESTERILIZED THE DEVICE. THEREFORE, THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM => NOT POSSIBLE -> IFU D011500245 CHAPTER ¿WARNINGS¿ RE-USE OF A SINGLE USE DEVICE THAT HAS COME INTO CONTACT WITH BLOOD, BONE, TISSUE OR OTHER BODY FLUIDS MAY LEAD TO PATIENT OR USER INJURY. POSSIBLE RISKS ASSOCIATED WITH RE-USE OF A SINGLE USE DEVICE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL FAILURE AND TRANSMISSION OF INFECTIOUS AGENTS. IN ADDITION, NO INFORMATION RECEIVED, THAT A SINGLE USE DEVICE WAS REUSED. THEREFORE, THIS CAUSE CAN BE EXCLUDED. - 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. THEREFORE, THIS CAUSE CAN BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 15 DAYS POST IMPLANTATION DUE TO INFECTION. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES 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 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 (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY TWO WEEKS POST IMPLANTATION DUE TO INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM: UNKNOWN BIOLOX HEAD, CATALOG #: UNKNOWN, LOT #: UNKNOWN. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00411. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN UNKNOWN ALLOCLASSIC CUP ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224196 BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2828166

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ALLOCLASSIC INSERT, ITEM# 00877401032, LOT# 282257