BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DYNESYS SPINE IMPL

    MDR report key: 6854423 · Received September 11, 2017

    Report

    Report Number
    0009613350-2017-01211
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBERS ARE AVAILABLE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT TO THE COMPLAINANT. AT ZIMMER GMBH 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 GMBH 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. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DYNESYS IMPLANT BEFORE 2009 AND UNDERWENT REVISION SURGERY DUE TO METAL ALLERGY, ELECTRICAL FEELINGS AND NOISE IN HIS EAR. THE SYMPTOMS CEASED AFTER REVISION SURGERY. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. THOSE DOCUMENTS WERE REQUESTED AT THE COMPLAINANT AND ARE CURRENTLY NOT AVAILABLE. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: "INSTRUCTION LEAFLET FOR ENDOPROSTHESES" WAS REVIEWED. THIS LEAFLET, WHICH IS AVAILABLE IN THE PRODUCT PACKAGES, PROVIDES INFORMATION ABOUT RELEVANT CONTRAINDICATIONS, HAZARDS, ADVERSE EFFECTS, WARNINGS, PRECAUTIONS, STERILIZATION CONDITIONS AS WELL AS STORAGE AND HANDLING OF THE DEVICE. ¿ALLERGY TO THE IMPLANTED MATERIAL, ABOVE ALL TO METAL (E.G., COBALT, CHROMIUM, NICKEL, ETC.)¿ IS INDICATED AS ONE OF THE CONTRAINDICATIONS IN THE LEAFLET. MOREOVER, IT IS STATED UNDER THE WARNINGS>PREOPERATIVE SECTION THAT ¿ALTHOUGH ALLERGIES AND OTHER REACTIONS TO IMPLANT MATERIALS ARE UNUSUAL, THEY SHOULD BE TAKEN INTO CONSIDERATION AND EXCLUDED BEFORE SURGERY.¿ ADDITIONALLY, UNDER THE WARNINGS>SIDE EFFECTS SECTION, IT IS INDICATED THAT POSSIBLE CONSEQUENCES OF AN IMPLANT INCLUDE "TISSUE REACTIONS AND ALLERGIES TO THE PRODUCTS OF CORROSION OR WEAR AND CEMENT PARTICLES". FURTHER, PACKAGE INSERT USED FOR DYNESYS® DYNAMIC STABILIZATION SYSTEM AND DYNESYS® TOP-LOADING SPINAL SYSTEM (HA), STATES THAT ¿ALLERGIC REACTION TO IMPLANT COMPONENTS.¿ IS A CONTRAINDICATION. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: WEAR PARTICLES CAN GET INTO THE WOUND CAN CAUSE FOREIGN BODY REACTION DUE TO PET/PCU WEAR PARTICLES GENERATED BY SPACER. (MICROMOTION) => POSSIBLE, IT CANNOT BE EXCLUDED THAT SOME PARTICLES GOT INTO THE WOUND. HOWEVER, BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY CERTIFY THE SUITABILITY OF THE MATERIAL. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. ADVERSE BIOLOGICAL REACTION DUE TO MANUFACTURING RESIDUALS NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. NON-BIOCOMPATIBLE MATERIAL ENTER WOUND AND CAN CAUSE ADVERSE BODY REACTION DUE TO DEVICE AND/OR PACKAGING MATERIAL NOT BIOCOMPATIBLE. NOT POSSIBLE -> BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY CERTIFY THE SUITABILITY OF THE MATERIAL. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. NON-BIOCOMPATIBLE MATERIAL ENTER WOUND AND CAN CAUSE ADVERSE BODY REACTION DUE TO DEVICE AND/OR PACKAGING MATERIAL. CONTAINS PHTHALATES. NOT POSSIBLE -> BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY CERTIFY THE SUITABILITY OF THE MATERIAL. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE. EVALUATION ASSESSMENT. NON-BIOCOMPATIBLE MATERIAL ENTER WOUND AND CAN CAUSE ADVERSE BODY REACTION DUE TO LEAKAGE OF SUBSTANCES WHICH ARE CYTOTOXIC NOT POSSIBLE -> BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY CERTIFY THE SUITABILITY OF THE MATERIAL. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DYNESYS IMPLANT AND UNDERWENT REVISION SURGERY DUE TO METAL ALLERGY, ELECTRICAL FEELINGS AND NOISE IN HIS EAR. THE SYMPTOMS CEASED AFTER REVISION SURGERY. THIS CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE. THERE IS NO MEDICAL DOCUMENT CONFIRMING WHETHER THE PATIENT HAS SOME ALLERGY AGAINST THE MATERIALS USED. AS IT IS INDICATED IN THE PACKAGE INSERT ¿INSTRUCTION LEAFLET FOR ENDOPROSTHESES¿ AND " DYNESYS® DYNAMIC STABILIZATION SYSTEM AND DYNESYS® TOP-LOADING SPINAL SYSTEM (HA)" ALLERGIES SHOULD BE TAKEN INTO CONSIDERATION AND ARE CONTRAINDICATIONS. FOR EXAMPLE A PREOPERATIVE TEST COULD POTENTIALLY IDENTIFY AN ALLERGY TO THE IMPLANT MATERIALS PATIENT AND AVOID POTENTIAL ADVERSE REACTIONS. IT IS POSSIBLE THAT THE PATIENT IS ALLERGIC TO ONE IMPLANT MATERIALS OF A DYNESIS SPINE IMPLANT, HOWEVER, THIS CANNOT BE CONFIRMED. THEREFORE, IT IS IMPOSSIBLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THE REPORTED EVENT. 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

    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. 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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DYNESYS IMPLANT (REF#UNKNOWN) BEFORE 2009 AND UNDERWENT A REVISION SURGERY (DATE UNKNOWN) DUE TO METAL ALLERGY, ELECTRICAL FEELINGS AND NOISE IN HIS EAR. THE SYMPTOMS CEASED AFTER REVISION SURGERY. NOTE: IT WAS INITIALLY REPORTED, THAT THE PATIENT IS EXPERIENCING THE SAME SYMPTOMS FROM HIS HIP IMPLANT WHICH IS REPORTED IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DYNESYS IMPLANT ON AN UNKNOWN SIDE BEFORE 2009 AND THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO METAL ALLERGY, ELECTRICAL FEELINGS AND NOISE IN HIS EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635489 UNKNOWN DYNESYS SPINE IMPL UNKNOWN DYNESYS SPINE IMPL NQP ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R