BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVITAN HIP STEM

    MDR report key: 6614291 · Received June 6, 2017

    Report

    Report Number
    0009613350-2017-00769
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 8, 2017
    Report Date
    June 6, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWL
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE CASE AT HAND WAS TAKEN FROM A JOURNAL ARTICLE IT IS NOT SUSPECTED THAT THE DEVICE OR ADDITIONAL INFORMATION IS BEING SUBMITTED FOR REVIEW. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 IN THE JOURNAL ARTICLE THAT STEM SUBSIDENCE OF 0-4MM WAS NOTICED IN 41 PATIENTS, OF 5-10MM IN 17 CASES AND WAS GREATER THAN 10MM IN 11 PATIENTS. 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. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: ASEPTIC LOOSENING DUE TO INSUFFICIENT PRIMARY 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. ASEPTIC LOOSENING DUE TO INSUFFICIENT SECONDARY STABILITY POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO MOVEMENT OF IMPLANT PART (PROXIMAL OR DISTAL) LEADS TO WEAR => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO DESIGN LEADING TO STRESS SHIELDING => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOOSENING OF THE IMPLANT DUE TO WRONG BEHAVIOR OF PATIENT, HIGH PATIENT ACTIVITY, PATIENT DISREGARDS LIMITS OF THE DEVICE => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO SURGEON UNFAMILIAR WITH IMPLANTATION TECHNIQUE OF THIS STEM DESIGN (EARLY STABILITY, E.G. INCORRECT USE ETC.) => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. MIGRATION OF STEM SHORT AND LONG TERM, SPLITTING OF FEMUR, IMPROPER INITIAL SETTING OF THE IMPLANT DUE TO WRONG SELECTION OF DISTAL AND PROXIMAL PART, PLANNING, OPERATION TECHNIQUE AND USE OF INSTRUMENTS => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. IMPLANT AND RASP SIZES USED AND ADHERENCE TO SURGICAL TECHNIQUE ARE UNKNOWN. THEREFORE CANNOT BE EXCLUDED. MIGRATION AND/OR LOOSENING OF IMPLANT - STEM BREAKAGE DUE TO MISSING PROX. BONE SUPPORT AND HEAVY AND ACTIVE PATIENT DUE TO SURGEON UNFAMILIAR WITH THE CORRECT INDICATIONS AND CONTRAINDICATIONS => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO LMS MARKING IS NOT READABLE UNDER OR LIGHTING, MARKING PARAMETERS ARE NOT SUFFICIENT ENOUGH, THEREFORE WRONG COMBINATION OF COMPONENTS => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOOSENING OR FRACTURE OF COMPONENTS DUE TO PATIENT WITH HIGH BODY WEIGHT LEADING TO INCREASED WEAR => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. LOOSENING OR FRACTURE OF IMPLANT DUE TO INSUFFICIENT BONY SUPPORT OF IMPLANT => POSSIBLE: THE ONLY INFORMATION AVAILABLE IS THE EVENT AS REPORTED IN THE JOURNAL ARTICLE. NO OTHER DETAILS ARE AVAILABLE, THEREFORE THIS CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO DESIGN LEADING TO STRESS SHIELDING => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. CONCLUSION SUMMARY: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿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. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A REVITAN HIP STEM (CATALOGUE NUMBER UNKNOWN) ON AN UNKNOWN SIDE (EXACT DATE NOT REPORTED). CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO IMPLANT SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396922 REVITAN HIP STEM REVITAN STEM KWL ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other