BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/200

    MDR report key: 7453908 · Received April 24, 2018

    Report

    Report Number
    0009613350-2018-00460
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    April 1, 2018
    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
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: 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: FRACTURE OF DISTAL REVITAN STEM. EVENT DESCRIPTION: THE REVITAN SHAFT WAS REVISED AFTER ABOUT 10 YEARS AND 7 MONTHS IN VIVO DUE TO A BREAKAGE OF THE CONNECTING PIN. REVIEW OF RECEIVED DATA: OPERATION REPORT IMPLANTATION, (B)(6) 2007. THERE ARE TWO IMAGES, EACH WITH ONE SIDE OF THE IMPLANTATION REPORT. BASED ON THE CONTENT AND THE WORDS AT THE END OF THE FIRST PAGE OR THE BEGINNING OF THE SECOND PAGE, IT IS ASSUMED THAT ONE PAGE IS MISSING. UNFORTUNATELY, THE SECTION DESCRIBING THE IMPLANTATION OF THE REVITAN STEM AND THE COMPLETE CUP-INLAY REPLACEMENT IS MISSING. FOR THIS REASON, ONLY THE BEGINNING AND END OF THE PROCEDURE ARE SUMMARIZED, THE MISSING PAGE IS ONLY NOTED. DIAGNOSIS: SUSPICION OF MECHANICAL STEM LOOSENING ON THE RIGHT IN THE CONDITION AFTER JOINT REPLACEMENT ON THE RIGHT SIDE ON (B)(6) 2002 AND LEFT SIDE IN (B)(6) 1998. PROCEDURE: CUP, INLAY AND STEM REVISION. INDICATION: THE PATIENT HAD A DEBILITATING COXARTHROSIS ON BOTH SIDES AT A VERY EARLY STAGE, SO THAT A JOINT REPLACEMENT WAS IMPLANTED ON THE RIGHT AND LEFT. "THE PATIENT IS EXTREMELY ATHLETIC, OF STOUT BUILD AND A PROFESSIONAL BUTCHER." AFTER INITIALLY UNPROBLEMATIC COURSE THERE IS PULLING PAIN FOR TWO YEARS RIGHT. INITIALLY THERE WERE NO RADIOLOGICAL CHANGES. LATER, IT CAME TO THE SINKING OF THE STEM AND THE FORMATION OF A CYST. TO PRECLUDE ADDITIONAL LOOSENING AND INFECTION, GRANULOCYTE SCINTIGRAPHY WAS PERFORMED. THE CUP IS PERFECT, BUT THE STEM INDICATES MECHANICAL LOOSENING WITHOUT INFECTION. SUMMARY OF THE SURGERY: AFTER OPENING THE JOINT, INTRAARTICULARLY, A CLEAR, GREENISH-BLACK DISCOLORED STRUCTURE APPEARED IN THE SENSE OF A METALLOSIS WITH A MINIMAL, CLEAR EFFUSION. SYNOVIAL TISSUE AND ADDITIONAL HISTOLOGICAL TISSUE SAMPLES ARE TAKEN. AFTER COMPLETE SYNOVECTOMY AND SCAR TISSUE REMOVAL, LUXATION SUCCEEDS. THE SHAFT IS ESPECIALLY MOBILE IN THE LONGITUDINAL DIRECTION AND CAN BE EASILY KNOCKED OUT. A 10 CM FRONTAL OSTEOTOMY THROUGH THE GREATER TROCHANTER IS PERFORMED AND OPENED LIKE A WING. THE CEMENT HAS TO BE CHISELLED OUT VERY LABORIOUSLY. BEFORE CLAPPING, A CERCLAGE IS PLACED IMMEDIATELY DISTAL TO THE OSTEOTOMY FOR PROTECTION. THERE IS NO STRIKING DISLOCATION TENDENCY WITH THE 36ER HEAD. AFTER EXTENSIVE RINSING, THE DEFINITIVE STEM IS INSERTED AND REPOSITIONED WITH A MIDDLE HEAD. THERE ARE THREE MORE CERCLAGEN ATTACHED. THERE WAS AN ADDITIONAL FRACTURE OF THE DORSAL ATTACHMENT, WHICH IS, HOWEVER, HELD BY THE ATTACHED CERCLAGEN. THERE IS NO RISK OF THE TROCHANTER MAJORS GLIDING UP. AFTER EXTENSIVE WOUND IRRIGATION, THE WOUND IS CLOSED AGAIN. X-RAYS: X-RAY IMAGE DATED 2015. THE RADIOGRAPH IS DATED BY HAND WITH 2015. RED ARROWS ARE DRAWN AROUND THE CUP. THERE IS AN UNCEMENTED REVITAN STEM IMPLANTED. THE DISTAL THIRD OF THE REVITAN STEM IS NOT SHOWN. THE FEMUR IS PROVIDED WITH FOUR CERCLAGES, ONE OF WHICH IS OVERGROWN WITH BONE. X-RAYS UNDATED N°1: THE UNDATED RADIOGRAPH SHOWS THE RIGHT HIP. BASED ON THE DETAINED STATE, IT IS ASSUMED TO BE AN IMAGE JUST BEFORE THE REVISION SURGERY. THE DISTAL THIRD OF THE REVITAN STEM IS NOT SHOWN. WITH A BLACK PEN VARIOUS MARKERS ARE DRAWN IN E.G. ARROWS AROUND THE CUP, THE WORD "BREAK", LINES AND BORDERS. THE CONNECTING PIN OF THE REVITAN SHAFT APPEARS TO BE BROKEN AND THE PROXIMAL FRAGMENT IS TILTED MEDIALLY. DUE TO THIS TILTING, A FINE SCLEROSIS BORDER, AS WELL AS A DISTANCE BETWEEN THE BONE AND THE IMPLANT, CAN BE RECOGNIZED ON THE METAPHYSEAL SIDE. THE PROXIMAL CERCLAGE IS FRACTURED MEDIALLY. COMPARED TO THE PREVIOUS X-RAY IMAGE, A HEM FORMATION UP TO THE LEVEL OF THE DISTAL CERCLAGE CAN BE RECOGNIZED MEDIALLY AND LATERALLY IN THE AREA AROUND THE DISTAL SHAFT PART. CONTRAST AND BRIGHTNESS OF BOTH X-RAY IMAGES ARE NOT COMPARABLE. FOR BOTH TIME POINTS, ONLY ONE LEVEL IS AVAILABLE FOR ASSESSMENT AND THE SHAFT IS ONLY PARTIALLY SHOWN IN BOTH X-RAY IMAGES. IN THE COMPARISON OF THE X-RAY IMAGES, A SUBTLE HEM FORMATION SEEMS TO BE RECOGNIZABLE AROUND THE CUP WITHOUT NOTICEABLE CHANGES IN POSITION. THE CUP APPEARS TO BE RELATIVELY STEEP, BUT AN EXACT ASSESSMENT IS NOT POSSIBLE DUE TO THE SOLE REPRESENTATION OF THE RIGHT HIP JOINT. X-RAYS UNDATED N°2: A SECOND UNDATED RADIOGRAPH SHOWS THE COMPLETE REVITAN SHAFT. THE PLANNING SKETCHES FOR THE NEW PROSTHESIS CAN BE SEEN ON THE RADIOGRAPH. DUE TO THE POOR QUALITY, AN EVALUATION OF THE X-RAY IMAGE IS CANNOT BE PERFORMED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE CONNECTING PIN OF THE REVITAN STEM IS BROKEN IN THE NON-IRRADIATED AREA APPROXIMATELY 3 MM DISTAL TO THE PROXIMAL END OF THE DISTAL PORTION. THE PROXIMAL FRAGMENT OF THE CONNECTING PIN IS FIXEDLY MOUNTED IN THE PROXIMAL PART OF THE STEM. THE LOCKING NUT IS ALSO FIRMLY SITTING ON THE THREAD OF THE CONNECTING PIN. THE FRACTURED SURFACES SHOW A FATIGUE FRACTURE STARTING FROM THE POSTEROLATERAL SIDE. THE BREAKAGE EXIT APPEARS SHINY. THE LAST PART OF THE REST BREAK IS SLIGHTLY POLISHED. AS FAR AS CAN BE SEEN MACROSCOPICALLY, NO FRACTURE-INDUCING OR PROMOTING DEFECTS ARE TO BE SEEN ON THE FRACTURE SURFACES. THE PROXIMAL FRAGMENT SHOWS A SEMI-CIRCUMFERENTIAL STRIP WITH SURFACE CHANGES ON THE LATERAL SURFACE OF THE CONNECTING PIN ALONG THE FRACTURE SURFACE. IT IS A MIXTURE OF METALLIC LUBRICATION, POLISHING AND CORROSION. A SMALL CRACK FROM THE FRACTURE SURFACE INTO THE LATERAL SURFACE CAN BE SEEN NEAR THE FRACTURE EXIT. THERE ARE SOME SCRATCHES AND NOTCHES IN THE BLASTED AREA OF THE CONNECTING PIN. THE FRONT SURFACE OF THE PROXIMAL PART HAS VERY SLIGHT SCRATCHES AND AN IMPRESSION NEXT TO THE LATERAL SHOULDER. THE STEM CONE SHOWS A CIRCUMFERENTIAL, DARK DISCOLORED LINE. THE STEM CONE SHOWS SURFACE CHANGES WITH LONGITUDINAL STRUCTURES PARALLEL TO THE CONE AXIS IN TWO SMALL AREAS (LATERAL AT THE PROXIMAL END AND ANTEROMEDIAL APPROXIMATELY IN THE MIDDLE). THE REASON IS UNKNOWN. AT THE PROXIMAL PART OF THE SHAFT NO BONE ACCRETIONS ARE VISIBLE. THERE ARE FINE SCRATCHES IN THE NECK / SHOULDER AREA, WHILE THE ANCHORING AREA, WITH THE EXCEPTION OF THE MEDIAL SIDE, SHOWS VARIOUS COARSER SCRATCH MARKS, NOTCHES AND POLISHED AREAS. ALL THESE DAMAGES WERE PROBABLY CAUSED BY THE REVISION OPERATION. FINE, POLISHED LINES CAN BE SEEN ON THE ANTERIOR SIDE OF THE ANCHORING AREA. THE DISTAL PART OF THE STEM HAS A PARTLY POLISHED IMPRESSION OF THE SETTING INSTRUMENT ON THE END FACE. ON THE LATERAL HALF OF THE END FACE AN EXTERNALLY DEFORMED AND ABRADED AREA IS VISIBLE. THIS LOCATION IS CONSISTENT WITH THE POSITION OF THE INDENTATION ON THE FACE OF THE PROXIMAL PORTION OF THE STEM. IT IS BELIEVED THAT THESE TWO DAMAGES WERE CAUSED BY AN INSTRUMENT DURING THE REVISION OPERATION. IN ADDITION, THE LATERAL CORNER OF THE POSTERIOR SHOULDER IS ABRADED. THE ANCHORING SURFACE OF THE DISTAL PART HAS VARIOUS DAMAGE FROM INSTRUMENTS INCLUDING THE LATERALLY SET BOREHOLE, WHICH PROBABLY OCCURRED DURING THE REMOVAL OF THE PART DURING THE REVISION OPERATION. ON THE MEDIAL SIDE OF THE STEM THERE IS AN ADDITIONAL MECHANICAL TREATMENT. IT IS BELIEVED THAT THIS ALSO OCCURRED DURING REMOVAL OF THE DISTAL PART. BONE ADULTERATION CAN BE SEEN MAINLY IN THE DISTAL HALF OF THE ANCHORING SURFACE. SCANNING ELECTRON MICROSCOPE (SEM): THE FRACTURE SURFACE AND THE ADJACENT LATERAL SURFACE OF THE CONNECTING PIN OF THE PROXIMAL FRAGMENT WERE EXAMINED IN DIFFERENT AREAS IN A SCANNING ELECTRON MICROSCOPE. AT THE FRACTURE EXIT, THE FRACTURE STRUCTURE IS LEVELED. IN THE MIDDLE OF THE FRACTURE SURFACE THE FATIGUE FRACTURE STRUCTURE TYPICAL FOR THE MATERIAL CAN BE SEEN. APPROXIMATELY IN THE LAST THIRD OF THE FRACTURE SURFACE, A MIXTURE OF RESIDUAL AND FATIGUE FRACTURE STRUCTURE CAN BE SEEN. AT THE END OF THE FRACTURE SURFACE, THE FRACTURE SURFACE STRUCTURE IS LEVELED. THE LATERAL SURFACE OF THE CONNECTING PIN SHOWS GREASING AND AREAS WITH CORROSION AND FRETTING. IN THE AREA OF THE BREAKAWAY EXIT, THE LATERAL SURFACE IS TRITURATED. CRACKS IN THE MATERIAL COULD BE IDENTIFIED LATERALLY OF THE FRACTURE EXIT. CONCLUSION: THE REVITAN SHAFT WAS REVISED AFTER ABOUT 10 YEARS AND 7 MONTHS IN VIVO DUE TO A BREAKAGE OF THE CONNECTING PIN. DUE TO THE MEDIAL TILTING OF THE SHAFT IN THE SECOND X-RAY IMAGE, THE ORIGINAL POSITION OF THE SHAFT IS VISIBLE IN THE BONE. FROM THIS IT CAN BE CONCLUDED THAT THIS CLEARANCE WAS PROBABLY ALREADY PRESENT MEDIAL BEFORE TILTING OF THE SHAFT. COMPARED TO THE FIRST RADIOGRAPH OF 2015, THIS FREE SPACE IS NOT RECOGNIZABLE THERE. IN THE ANCHORAGE AREA OF THE PROXIMAL PART OF THE REVITAN SHAFT, FINE, POLISHED STROKES WERE FOUND, WHICH CAN INDICATE A RELATIVE MOVEMENT BETWEEN IMPLANT AND BONE. THIS RELATIVE MOVEMENT COULD HAVE CONTRIBUTED TO THE FRACTURE OF THE PROXIMAL CERCLAGE. FURTHERMORE, ONLY THE DISTAL HALF OF THE DISTAL SHAFT PART HAS BONE ADHESIONS. RADIOLOGICALLY, A HEM FORMATION ON THE DISTAL SHAFT PORTION SHOWN CAN BE SEEN. THE PHENOMENA DESCRIBED ABOVE MAY INDICATE A LOOSENING OF THE REVITAN STEM UP TO THE LEVEL OF THE DISTAL CERCLAGE. THE BREAKAGE OF THE CONNECTING PIN OCCURRED DUE TO MATERIAL FATIGUE. ON THE FRACTURE SURFACE, NO FRACTURE-INDUCING OR FAVORING DEFECTS COULD BE FOUND WITH THE INVESTIGATIONS CARRIED OUT. THE FRACTURE IS APPROXIMATELY 3 MM DISTAL TO THE PROXIMAL END OF THE DISTAL PORTION OF THE REVITAN STEM. SURFACE CHANGES (MIXTURE OF METALLIC LUBRICATION, POLISHING, CORROSION AND FRETTING) WERE OBSERVED ON THE OUTER SURFACE OF THE CONNECTING PIN. IN ADDITION, IN ONE AREA, CRACKS LATERALLY OF THE RUPTURE EXIT OF THE CONNECTING PIN WERE IDENTIFIED. IT IS UNKNOWN WHETHER THESE PHENOMENA ALREADY EXISTED BEFORE THE BEGINNING OF THE RUPTURE AND ARE RELATED OR EXCLUSIVELY TO BE CONSIDERED AS A BY-PRODUCT. THE SAME APPLIES TO THE FINE, POLISHED LINES IN THE ANCHORING AREA OF THE PROXIMAL PART OF THE REVITAN SHAFT AND THE FRACTURE OF THE PROXIMAL CERCLAGE. BASED ON THE INFORMATION AVAILABLE AND THE VISUAL ASSESSMENT, IT IS BELIEVED THAT PARTIAL LOOSENING OF THE REVITAN STEM OCCURRED AT SOME POINT DURING THE TIME IN VIVO. THIS COULD HAVE HAD AN INFLUENCE ON THE LOAD ON THE STEM AND FINALLY LED TO THE BREAKAGE OF THE CONNECTING PIN. IT IS NOT KNOWN IF, IN ADDITION TO THE SURFACE CHANGES ON THE CONNECTING PIN, THERE WERE OTHER FACTORS WHICH COULD HAVE INFLUENCED THE FRACTURE PROCESS. CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL ¿PIN BREAKAGES¿ OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER GMBH DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON JANUARY 13TH 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR THE CASE WAS RECEIVED AND IS FILED IN THIS REPORT. THE INVESTIGATION IS ONGOING. 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 · 0

    THE PATIENT HAD A REVITAN STEM IMPLANTED ON AN UNKNOWN SIDE ABOUT 10 YEARS AGO AND UNDERWENT REVISION SURGERY DUE TO STEM FRACTURE. IT IS ALSO REPORTED, THAT THERE IS NO TRAUMA OR OTHER CONDITIONS WHICH MIGHT HAVE CONTRIBUTED TO THE BREAKAGE OF THE IMPLANT AND THE REVISION SURGERY TOOK ALMOST 4 HOURS TO REMOVE THE STEM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14 CATALOG NO# 01.00402.055; LOT NO# 2384821, DURASUL, ALPHA INSERT, NN/36 CATALOG NO# 01.00013.714 ; LOT NO# 2212382, COCR HEAD, M, 36/0, TAPER 12/14 CATALOG NO# 01.01012.366 ; LOT NO#2395454. CONCOMITANT MEDICAL PRODUCTS - THERAPY DATE: (B)(6) 2018. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E FITMORE HIP STEM , K071723) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. 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. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT:0009613350-2018-00459. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A REVITAN STEM IMPLANTED ON AN UNKNOWN SIDE ABOUT 10 YEARS AGO AND UNDERWENT REVISION SURGERY DUE TO STEM FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296425 REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/200 REVITAN DISTAL STEM KWA ZIMMER GMBH N/A 2277741

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R