BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL TAPER LINER KK/40

    MDR report key: 7467823 · Received April 27, 2018

    Report

    Report Number
    0009613350-2018-00483
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 21, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PK091973
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: REF: 00-8770-040-01 ; LOT:2517870. YIELD:30. DELIVERED:30. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF: 00-8770-012-40 ; LOT:2517959. YIELD:27. DELIVERED:17. SCRAPPED:10. REASON FOR SCRAPPING: DIMENSION DEVIATION THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF: 29.00.39-100 ; LOT: 2520818. YIELD:100. DELIVERED:99. SCRAPPED:01. REASON FOR SCRAPPING: DAMAGE FROM WASHING 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: REVISION DUE TO INFECTION. EVENT DESCRIPTION: ACCORDING THE INCIDENT REPORT, THE PATIENT WAS IMPLANTED WITH METASUL HEAD CLS STEM ON (B)(6) 2009 AND UNDERWENT REVISION ON (B)(6) 2018 DUE TO SEPTIC MOBILIZATION OF STEM. REVIEW OF RECEIVED DATA: X-RAYS DATED (B)(6) 2018 2X PELVIS OVERVIEW / SECOND VIEW LEFT: ON THE LEFT SIDE CEMENTLESS TOTAL HIP ENDOPROSTHESIS WITH CORTICAL HYPERTROPHY CLEARLY VISIBLE IN THE COURSE OF THE STEM BELOW THE GREATER TROCHANTER AND MINOR. PROXIMALLY IN GRUEN ZONE 1 AND 7 (LATERAL / MEDIAL) RADIOLUCENT LINE, MORE PRONOUNCED IN THE AREA OF THE CALCAR IN ZONE 7. IN THE AP-PROJECTION IN THE AREA OF THE TROCHANTER MAJOR CLEARLY RECOGNIZABLE OSTEOLYTIC BONE STRUCTURE. IN THE 2ND LEVEL RECOGNIZABLE OSTEOLYSIS PROXIMAL STEM AREA AND UP TO DIAPHYSEAL REACHING VISIBLE RADIOLUCENT LINE POSTEROLATERAL AND ANTEROMEDIAL. IN THE AREA OF THE CUP NEAR TO THE IMPLANT CYSTOID LOOSENING OF THE BONE STRUCTURE IS DETECTABLE. PATIENT HISTORY: PATIENT STARTED TO SHOW PAIN IN THE THIGH AFTER 2 MONTHS OF SURGERY (PERFORMED IN 2009). RADIOGRAPHY AND TRIPHASIC SCINTIGRAPHY SHOWED A MOBILIZATION OF THE STEM. SUBSEQUENTLY, THE PATIENT PERFORMED AN ULTRASOUND-GUIDED NEEDLE ASPIRATION WHICH SHOWED A BACTERIAL POSITIVITY, SO THE PROSTHESIS EXPLANTATION WAS THE CONSEQUENCE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. STERILIZATION CERTIFICATES ARE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATIONS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW (METASUL HEAD): NON-STERILE DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE. NOT POSSIBLE. CLEANING PROCESS IS VALIDATED BY BIOCOMPATIBILITY SPECIFICATION DOCUMENT AND CHEMICAL CLEANLINESS OF METAL FEMORAL HEADS DOCUMENT. NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE. NOT POSSIBLE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING THE STERILIZATION SPECIFICATION. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE. NOT POSSIBLE THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED METASUL HEAD IS REUSED FOR NEW IMPLANTATION SURGERY. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE. POSSIBLE, NO INFORMATION ABOUT A PACKAGING ISSUE WAS REPORTED, HOWEVER CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO THE USER IS USING AN INADEQUATE RE-STERILIZATION PROCEDURE/IMPLANT IS FALLING ON THE FLOOR DURING HANDLING IN OR. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. ROOT CAUSE DETERMINATION USING RMW (METASUL LINER): NON-STERILE DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE. NOT POSSIBLE CLEANING PROCESS IS VALIDATED BY BIOCOMPATIBILITY SPECIFICATION DOCUMENT AND CHEMICAL CLEANLINESS OF METAL FEMORAL HEADS DOCUMENT. NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE AT SUPPLIER. NOT POSSIBLE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING THE STERILIZATION SPECIFICATION. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE. NOT POSSIBLE THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION. POSSIBLE, NO INFORMATION ABOUT A PACKAGING ISSUE WAS REPORTED, HOWEVER CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE RE-STERILIZATION PROCEDURE BY USER. POSSIBLE, IT IS UNKNOWN, IF THE DEVICE WAS RESTERILIZED, THEREFORE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO IMPLANT IS FALLING ON THE FLOOR DURING HANDLING IN OR. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. ROOT CAUSE DETERMINATION USING RMW (CLS STEM): ASEPTIC LOOSENING OF STEM, STRESS SHIELDING, BONE STOCK CHANGES, OSTEOLYSIS, BONE FRACTURE DUE TO INSUFFICIENT SECONDARY STABILITY DUE TO DESIGN. NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. NON-STERILE DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE. NOT POSSIBLE CLEANING PROCESS IS VALIDATED BY BIOCOMPATIBILITY SPECIFICATION DOCUMENT AND CHEMICAL CLEANLINESS OF METAL FEMORAL HEADS DOCUMENT. NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE. NOT POSSIBLE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING THE STERILIZATION SPECIFICATION. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE. NOT POSSIBLE THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION. POSSIBLE, NO INFORMATION ABOUT A PACKAGING ISSUE WAS REPORTED, HOWEVER CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO INADEQUATE RE-STERILIZATION PROCEDURE BY USER. POSSIBLE, IT IS UNKNOWN, IF THE DEVICE WAS RESTERILIZED, THEREFORE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO IMPLANT IS FALLING TO FLOOR DURING HANDLING IN OR. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY. POSSIBLE, IT CANT BE PROVED, THEREFORE CANNOT BE EXCLUDED. CONCLUSION SUMMARY: PATIENT UNDERWENT REVISION ON (B)(6) 2018 DUE TO SEPTIC MOBILIZATION OF STEM AFTER 8 YEARS 9 MONTHS IN-VIVO TIME. RADIOLOGICAL EVIDENCE OF OSTEOLYSIS IN THE STEM AND CUP AREA OBSERVED IN X-RAYS. A RELATIONSHIP IS POSSIBLE IN RELATION TO ANAMNESTIC BIOPSY DETECTION OF BACTERIA. WHETHER A LOOSENING OF THE IMPLANT COMPONENTS IS PRESENT CAN NOT BE ASSESSED WITH CERTAINTY ON THE BASIS OF THE AVAILABLE X-RAYS. THE RADIOLOGICALLY RECOGNIZABLE DISTAL HYPERTROPHY OF THE CORTICAL BONE IS DEFINED AS A CHANGE IN BONE DENSITY AT THE MEDIAL FEMUR. ALTERED BIOMECHANICAL CONDITIONS IN THE AREA OF THE PROXIMAL FEMUR AFTER IMPLANTATION OF A HIP ENDOPROSTHESIS LEAD TO PERIPROSTHETIC BONE REACTIONS AND MAY BE DUE TO INCREASED TRANSMISSION OF FORCE AS RADIOLOGICAL PHENOMENA OF CORTICAL AND CANCELLOUS COMPACTION WITH INCREASED BONE MASS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. STERILIZATION SPECIFICATION OF THE DEVICES CERTIFY THE SUITABILITY OF STERILIZATION. STERILIZATION CERTIFICATES ARE REVIEWED. THE STERILIZATION CERTIFICATES CONFIRM 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. HOWEVER, THE IFU 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 THE INFECTION INCLUDE CONTAMINATION OF THE PRODUCT DURING OP, DAMAGE OF THE PACKAGING DURING TRANSPORTATION, RESTERILIZATION OF THE DEVICE AND REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. HOWEVER, NO POSSIBLE RISKS COULD BE IDENTIFIED REGARDING THE OSTEOLYSIS AROUND THE STEM. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 -2018 -00482 -1, AND 0009613350 -2018 -00480 -1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH METASUL TAPER LINER KK/40 ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION AND SEPTIC MOBILIZATION OF THE STEM.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: MSUL HEAD 40 12/14 SZ S/-3.5 /-3.5, CATALOG NO# 00877004001 ; LOT NO# 2517870, CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14, CATALOG NO# 290039100 ; LOT NO# 2520818. SHELL WITH CLUSTER HOLES POROUS 56 CATALOG NO# 00875706001 ; LOT NO# 61254979. THERAPY DATE: (B)(6) 2018. 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

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION AND SEPTIC MOBILIZATION OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310518 METASUL TAPER LINER KK/40 METASUL LINER KWA ZIMMER GMBH N/A 2517959

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R