BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTAN, STEM, RIGHT, UNCEMENTED, 14, TAPER 12/14

    MDR report key: 7568289 · Received June 5, 2018

    Report

    Report Number
    0009613350-2018-00577
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    August 19, 2014
    Report Date
    September 4, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT`S WEIGHT WAS RECEIVED AS ADDITIONAL INFORMATION. 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).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: ITEM: METASUL, ALPHA INSERT, NN/28 ITEM#: 01.00010.414 LOT#: 2050391. ITEM: ACA ANCHORAGE CAP 64/NN ITEM#: 409.0148 LOT#: A995955 . ITEM: METASUL HD 28MM L 12/14 ITEM#: 19.28.07 LOT#: 2099721 . TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INLAY DISASSOCIATED. DHR-REVIEW: REF#: (B)(4). LOT#: 2050391 - YIELD: 20 - DELIVERED: 20 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: 2099721 - YIELD: 70 - DELIVERED: 70 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: A995955 - YIELD: 20 - DELIVERED: 20 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: 2076578 - YIELD: 25 - DELIVERED: 25 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A HIP IMPLANT ON (B)(6)2002 AND REVISED ON (B)(6)2014 DUE TO DISASSOCIATION OF THE INLAY. DURING SURGERY IT WAS FOUND THAT THE CONE OF THE STEM HAS BEEN DAMAGED. REVIEW OF RECEIVED DATA: - ONE X-RAY DATED (B)(6)2014 HAS BEEN RECEIVED AND REVIEWED BY A HCP. DUE TO THE CONTRAST OF THE PICTURE, THE INLAY IS NOT CLEARLY VISIBLE IN THE CUP. THEREFORE IT CANNOT BE CONFIRMED, THAT THE INLAY HAS LUXATED OR WHETHER THERE HAS BEEN WEAR. NO DAMAGE AT THE CONUS CAN BE SEEN. THE HUMERAL HEAD IS DISPLACED CRANIALLY, WHICH INDICATES AN ISSUE WITH THE INLAY. THE INCLINATION ANGLE OF THE CUP IS WITH 56° VERY STEEP AND OUTSIDE OF THE RECOMMENDED RANGE. THIS IS A RISK FACTOR FOR AN INCREASED WEAR RATE OF THE INLAY AND MIGHT HAVE LED TO THE LUXATION OF THE INLAY. THE STEM IS IN AN ORTHOGRADE POSITION. RADIOLOGIC THERE IS NO PROOF FOR A LOOSENING OF THE STEM AND CUP. HOWEVER, IN THE AREA OF THE CUP AND AT THE PROXIMAL AREA OF THE STEM THERE IS OSTEOLYSIS. THE CAUSE CANNOT BE DETERMINED FOR CERTAIN. - ONE SURGICAL REPORT FROM THE REVISION SURGERY ON (B)(6) 2014 HAS BEEN RECEIVED. DIAGNOSIS: INLAY-LUXATION WITH A METAL-ON-METAL ARTICULATION. DAMAGE TO THE CONE OF THE STEM AT THE HIGH HIP. ACETABULAR OSTEOLYSIS PAPROSKY LL. IT IS REPORTED THAT THE PATIENT NOTICED A SQUEAKING OF THE HIP WITHOUT ANY FURTHER SYMPTOMS. ON THE X-RAYS IT WOULD SEEM LIKE THE METAL INLAY AND THE PE GOT SEPARATED. THE STEM WOULD SHOW CLEAR SIGNS OF OSTERLYSIS IN THE PROXIMAL AREA. THERAPY: TOTAL HIP PROSTHESIS REVISION. DURING REVISION SURGERY IT WAS NOTED THAT THERE IS A 2-3MM DEEP RIDGE AT THE TRANSITION FROM NECK TO THE CONE CAUSED BY THE CONTACT WITH THE METAL INLAY. TWO DOCTOR LETTERS, DATED (B)(6) 2014 AND (B)(6)2014 HAVE BEEN RECEIVED. IT IS MENTIONED THAT THE X-RAY FROM (B)(6)2014 WOULD SHOW ADVANCED WEAR OF THE INLAY WITH A CRANIALISATION OF THE HEAD AS WELL AS TILTING OF THE INLAY IN THE CUP. FURTHER, THERE WOULD BE OSTEOLYSIS IN THE AREA OF THE PROXIMAL FEMUR AS WELL AS A BEGINNING OSTEOLYSIS IN THE AREA OF THE CUP. THIS MIGHT BE CAUSE DUE TO METAL PARTICLES. IT IS ASSUMED THAT THE CUP AND STEM ARE WELL SEATED. 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. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW FOR REF (B)(4) METASUL INLAY: - LOSS OF INSERT-SHELL CONNECTION, COMPONENT LOOSENING, DISLOCATION DUE TO INSUFFICIENT INSERT STABILITY DUE TO DESIGN (SNAP GEOMETRY). => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - ASEPTIC LOOSENING, OSTEOLYSIS DUE TO PE WEAR DUE TO MOTION BETWEEN INSERT AND SHELL. => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - ADVERSE BODY REACTION DUE TO METAL PARTICLES RELEASE (FRETTING BETWEEN SHELL AND STEM) LEADING TO SOFT TISSUE REACTION AND DAMAGE DUE TO IMPINGEMENT WITH STEM, LEADING TO DETACHMENT OF SANDWICH CONSTRUCTION, WEAR ON STEM NECK. => POSSIBLE, AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. THEREFORE, POSSIBLE CAUSE CANNOT BE EXCLUDED. - ASEPTIC LOOSENING, OSTEOLYSIS DUE TO RELEASE OF PE PARTICLES DUE TO MOTION BETWEEN INSERT AND POLAR PLUG. => POSSIBLE, AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. THEREFORE, POSSIBLE CAUSE CANNOT BE EXCLUDED. - ASEPTIC LOOSENING, OSTEOLYSIS DUE TO RELEASE OF PE PARTICLES DUE TO MOTION BETWEEN INSERT AND SCREW PLUG. => POSSIBLE, AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. THEREFORE, POSSIBLE CAUSE CANNOT BE EXCLUDED. - ASEPTIC LOOSENING, OSTEOLYSIS DUE TO RELEASE OF PE PARTICLES DUE TO MOTION BETWEEN INSERT AND BONE SCREW. => POSSIBLE, AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. THEREFORE, POSSIBLE CAUSE CANNOT BE EXCLUDED. - ASEPTIC LOOSENING, METALLOSIS, SOFT TISSUE DAMAGE DUE TO INAPPROPRIATE DESIGN CONCERNING TRIBOLOGICAL PERFORMANCE LEADING TO INCREASED WEAR PARTICLES FROM ARTICULATION. => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - CORROSION DAMAGE LEADS TO IMPAIRMENT OF IMPLANT PARTS OR FRACTURE DUE TO GENERAL CORROSION (CREVICE, FRETTING, PITTING, GALVANIC) OF IMPLANT DEVICE. => POSSIBLE, AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. THEREFORE, POSSIBLE CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO DESIGN SPECIFICATION NOT MET. => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - IMPLANT BREAKAGE DUE TO DESIGN SPECIFICATION NOT MET. => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. ROOT CAUSE DETERMINATION USING RMW FOR REF (B)(4) METASUL HEAD: - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM DUE TO EXCESSIVE WEAR DUE TO MICROMOTION IN TAPER CONNECTION BETWEEN STEM AND HEAD (E.G FRETTING). => POSSIBLE, NO FURTHER X-RAYS RECEIVED. NO DEVICES RECEIVED. - POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM DUE TO PE OR METAL PARTICLE RELEASE FROM ARTICULATION OR TAPER CONNECTION. => POSSIBLE, NO FURTHER X-RAYS RECEIVED. NO DEVICES RECEIVED. - METALOSIS DUE TO DESIGN SPECIFICATION NOT MET. => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, IMPLANT BREAKAGE, CORROSION, METALOSIS DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO HEAD IS IMPLANTED ON A DAMAGED STEM TAPER; USAGE OF A WET AND/OR UNCLEAN STEM AND/OR HEAD TAPER (PARTICLES BETWEEN STEM TAPER AND BALL HEAD TAPER). => POSSIBLE, NO DEVICES RETURNED FOR INVESTIGATION. - DAMAGED IMPLANT, DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LOOSENING OF COMPONENTS DUE TO EXPLANTED METASUL HEAD (WITH E.G. A DAMAGED TAPER AND/ OR SCRATCHES ON THE SURFACE) IS REUSED FOR NEW IMPLANTATION SURGERY. => POSSIBLE, IT IS POSSIBLE THAT THE HEAD WAS RE-USED. ROOT CAUSE DETERMINATION OF REF (B)(4) ACA CUP; SIMILAR DEVICE ARTICLE # 3536, ALLOCLASSIC CFS ANCHOR CUP 64 WAS CONSIDERED FMEA: - ASEPTIC LOOSENING DUE TO MOTION BETWEEN LINER AND CUP PRODUCING PE WEAR DEBRIS. => POSSIBLE: AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. NO PRODUCTS HAVE BEEN RETURNED FOR AN INVESTIGATION. - ASEPTIC LOOSENING, MIGRATION OF CUP SHORT TERM AND LONG TERM DUE TO INSUFFICIENT SECONDARY STABILITY DUE TO SURFACE DESIGN. => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - ASEPTIC LOOSENING DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO INSUFFICIENT BONY SUPPORT OF IMPLANT LEADING TO STRESS SHIELDING => POSSIBLE: AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THERE IS OSTEOLYSIS IN THE AREA OF THE CUP. ROOT CAUSE DETERMINATION USING DFMEA FOR REF (B)(4) STEM: - ASEPTIC LOOSENING DUE TO INSUFFICIENT SECONDARY STABILITY. => POSSIBLE: AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - METALOSIS, CORROSION, FRETTING, ASEPTIC LOOSENING DUE TO INADEQUATE CONNECTION OF HEAD AND STEM DUE TO WRONG DESIGN OF TAPER CONNECTION. => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - MIGRATION AND/OR LOOSENING DUE TO SURGEON UNFAMILIAR WITH THE CORRECT INDICATIONS AND CONTRAINDICATIONS. => POSSIBLE: AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - IMPINGEMENT WITH CUP DUE TO WRONG POSITIONING OF THE COMPONENTS. => POSSIBLE: AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE INCLINATION ANGLE OF THE CUP WAS FOUND TO BE VERY STEEP. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A HIP IMPLANT ON (B)(6) 2002 AND REVISED ON (B)(6)2014 DUE TO DISASSOCIATION OF THE METASUL INLAY. DURING SURGERY IT WAS FOUND THAT THE CONE OF THE STEM HAS BEEN DAMAGED. ACCORDING TO THE REVISION SURGERY REPORT, THE DIAGNOSIS FOR THE REVISION WAS A DISLOCATION OF THE METAL INLAY FROM THE SANDWICH POLYETHYLENE AND A LOOSENING OF THE STEM WHICH MIGHT HAVE BEEN CAUSED BY RELEASED METAL PARTICLES. MOREOVER, THERE HAS BEEN A DAMAGE TO THE FEMORAL CONE CAUSED BY THE CONTACT TO THE METAL INLAY. X-RAY REVIEW REVEALED THAT THE INCLINATION ANGLE WAS DETERMINED TO BE APPROXIMATELY 56° . THE TOO STEEPLY IMPLANTED CUP IS LIKELY TO HAVE CAUSED OR CONTRIBUTED TO AN INCREASED WEAR RATE OF THE INLAY, WHICH CONSEQUENTLY COULD HAVE LED TO A LUXATION OF THE INLAY AND A DECENTRATION OF THE HUMERAL HEAD. IT CAN BE ASSUMED THAT THE METAL ABRASION MENTIONED IN THE INVESTIGATION IS MOST LIKELY THE REASON FOR THE LOOSENING OF THE PROSTHETIC COMPONENTS. NO PRODUCTS WERE RETURNED FOR AN IN-DEPTH ANALYSIS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 - 00575 - 2, 0009613350 - 2018 - 00576 - 2.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: METASUL, ALPHA INSERT, NN/28, ITEM#: 01.00010.414, LOT#: 2050391. ITEM: ACA ANCHORAGE CAP 64/NN, ITEM#: 409.0148, LOT#: A995955. ITEM: METASUL HD 28MM L 12/14 , ITEM#: 19.28.07, LOT#: 2099721. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON JUNE 01, 2018 TO THE APPROPRIATE REPRESENTATIVES. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00575, 0009613350 - 2018 - 00576 . NOTE: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT TO REVISION SURGERY APPROXIMATELY TWELVE YEARS POST IMPLANTATION DUE TO DISLOCATION. IT WAS ALSO REPORTED THAT THE CONE OF THE STEM IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413587 OPTAN, STEM, RIGHT, UNCEMENTED, 14, TAPER 12/14 N/A KWA ZIMMER GMBH N/A 2076578

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R