BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULLER CUP HIP IMPLANT

    MDR report key: 6636955 · Received June 13, 2017

    Report

    Report Number
    0009613350-2017-00846
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    March 7, 2017
    Report Date
    June 13, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    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

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 5, 2017. THE RESULTS OF THE PROVIDED INFORMATION WERE PROVIDED TREND ANALYSIS: DURING THE TREND ANALYSIS, NO TREND WAS IDENTIFIED. DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE THIRD E-MAIL ATTEMPT REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT ON JULY 6, 2017. 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: THE JOURNAL ARTICLE REPORTS NINE CASES OF CUP MIGRATION OVER MORE THAN 5 MM. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: ASEPTIC LOOSENING DUE TO WEAR (RELEASE OF PE PARTICLES DUE TO ARTICULATION MOTION) => POSSIBLE: NO PRODUCT OR DOCUMENTATION WAS PROVIDED FOR INVESTIGATION. THEREFORE WEAR CAN NOT BE EXCLUDED. EXCESSIVE WEAR, FRACTURE -> ASEPTIC LOOSENING DUE TO LOSS OF MECHANICAL PROPERTIES DUE TO AGING IN VIVO => POSSIBLE: NO PRODUCT OR DOCUMENTATION WAS PROVIDED FOR INVESTIGATION. THEREFORE LOOSENING DUE TO PRODUCT AGING CAN NOT BE EXCLUDED. LOOSENING DUE TO STRESS PEAKS IN CEMENT INTERFACE DUE TO DEFORMATION OF CUP (WALL THICKNESS) => POSSIBLE: NO PRODUCT WAS RETURNED FOR INVESTIGATION. THEREFORE CAN NOT BE EXCLUDED. FURTHER IT IS UNKNOWN WHETHER THE SURGEON WAS FOLLOWING THE SURGICAL TECHNIQUE DOC (B)(4). FRACTURE OF THE CUP, ASEPTIC LOOSENING, MIGRATION OF THE CUP DUE TO INSUFFICIENT MATERIAL THICKNESS DUE TO WRONG DESIGN / INSUFFICIENT FATIGUE STRENGTH OF MATERIAL => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS. ASEPTIC LOOSENING DUE TO LOSS OF BINDING SAFETY OF CEMENT INTERFACES: BONE ¿ BONE CEMENT - CUP => POSSIBLE: AS THE AFFECTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION. FAILURE OF IMPLANT (E.G. EXCESSIVE WEAR, FRACTURE, MIGRATION ETC.) DUE TO COMBINATION WITH NOT COMPATIBLE ZIMMER PRODUCTS (FEMORAL HEAD, RING / CAGE) => POSSIBLE: AS THE REFERENCE NUMBERS OF THE PRODUCTS IMPLANTED WERE NOT PROVIDED, A COMBINATION WITH NOT COMPATIBLE PRODUCTS CAN NOT BE EXCLUDED. DEFORMATION OF CUP --> HIGH TORQUE, INCREASED WEAR --> LOOSENING DUE TO IMPLANTATION WITHOUT (APPROPRIATE) REINFORCEMENT RING / CAGE (MANDATORY FOR SMALL PE CUP SIZES) => POSSIBLE: AS IT IS UNKNOWN, WHAT PRODUCTS WERE IMPLANTED AND THE SURGICAL PROCEDURES FOR THE INDIVIDUAL SURGERIES WERE NOT PROVIDED. HOWEVER, A REINFORCEMENT RING WAS IMPLANTED BUT NO INFORMATION ON PRODUCT REFERENCE NUMBERS WERE PROVIDED, A COMBINATION WITH AN INAPPROPRIATE RING CAN NOT BE EXCLUDED. FRACTURE / DAMAGE / LOOSENING OF IMPLANT DUE TO WRONG BEHAVIOR OF PATIENT HIGH PATIENT ACTIVITY OR PATIENT DISREGARDS LIMITS OF THE DEVICE => POSSIBLE: THE DETAILS ABOUT PATIENTS BEHAVIOR OR ACTIVITY LEVEL IS UNKNOWN. -MIGRATION OF CUP, ASEPTIC LOOSENING DUE TO USE OF IMPLANT OUTSIDE INDICATION RANGE, E.G. INSUFFICIENT BONY SUPPORT OF IMPLANT => POSSIBLE: DETAILS ABOUT PATIENT ANATOMY AND BONE STRUCTURE ARE UNKNOWN. USE OF WRONG IMPLANT SIZE / USE WITHOUT CAGE/RING (ASEPTIC LOOSENING, MIGRATION OF CUP SHORT AND LONG TERM) DUE TO LABEL NOT READABLE DUE TO WRONG MARKING SPECIFICATIONS => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS. MIGRATION AND / OR LOOSENING OF CUP, DISLOCATION OF HEAD DUE TO SURGEON UNFAMILIAR WITH IMPLANTATION TECHNIQUE OF IMPLANT => POSSIBLE: AS IT IS UNKNOWN IF SURGEON IS FAMILIAR WITH THE SURGICAL TECHNIQUE AND IF THE SURGEON APPLIED THE PRESCRIBED THE CORRESPONDING SURGICAL TECHNIQUE AT ALL. LOOSENING OR FRACTURE OF COMPONENTS DUE TO PATIENT WITH HIGH BODY WEIGHT LEADING TO INCREASED WEAR => POSSIBLE: DETAILS ABOUT PATIENT ANATOMY ARE UNKNOWN. ASEPTIC LOOSENING DUE TO INSUFFICIENT SECONDARY (LONG TERM) STABILITY => POSSIBLE: AS NO PRODUCT NOR DOCUMENTATION WAS RETURNED FOR INVESTIGATION, WE CAN NOT EXCLUDE AN INSUFFICIENT SECONDARY STABILITY IN THIS SPECIFIC CASE. HOWEVER, THE CLINICAL EVALUATION REPORT MENTIONS THE POTENTIAL RISK TO EXPERIENCE ASEPTIC LOOSENING IS DEEMED ACCEPTABLE. 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 DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS . ASEPTIC LOOSENING DUE TO INADEQUATE CEMENT DISTRIBUTION DUE TO IMPLANT DESIGN => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS. MIGRATION AND/OR LOOSENING OF COMPONENTS DUE TO SURGEON UNFAMILIAR WITH CORRECT INDICATIONS AND CONTRAINDICATIONS => POSSIBLE: IT IS UNKNOWN WETHER THE SURGEON WAS FOLLOWING THE SURGICAL TECHNIQUE. INDICATIONS AND CONTRAINDICATIONS ARE MENTIONED IN IFU (B)(4). 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. COMPLAINTS RELATED TO SAME ARTICLE: (B)(4). ZIMMER GMBH CONSIDER THIS CASE AS CLOSED. ZIMMER 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NINE PATIENTS WERE IMPLANTED AN UNKNOWN MULLER CUP HIP IMPLANT ON AN UNKNOWN SIDE (EXACT DATE NOT REPORTED). CURRENTLY, THE PATIENTS ARE BEING MONITORED DUE TO IMPLANT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419590 MULLER CUP HIP IMPLANT MULLER CUP HIP KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1