BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN DIST. STRAIGHT 18/260

    MDR report key: 8063204 · Received November 13, 2018

    Report

    Report Number
    0009613350-2018-01148
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 17, 2018
    Report Date
    May 20, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K071723
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: BRAND NAME, COMMON DEVICE NAME, LOT#, EXPLANT DATE, CONCOMITANT MEDICAL PRODUCTS, IF FOLLOW-UP, WHAT TYPE, DEVICE MANUFACTURE DATE. CORRECTION: DATE OF REPORT, EVENT, CONCOMITANT MEDICAL PRODUCTS, PMA/510K, DEVICE EVALUATED BY MFR. CONCOMITANT MEDICAL PRODUCTS ACCORDING: REVITAN PROX. CYLINDRICAL 65, REF#: (B)(4), LOT#: 2808741, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, REF#: (B)(4), LOT#: 2790010, FITMORE®, SHELL WITH SCREW CONES, REF#: (B)(4), LOT#: 2805488, DURASUL®, ALPHA INSERT, KK/36, REF#: (B)(4), LOT#: 2795101. DHR-REVIEW: REF#: (B)(4), LOT#: 2612589, 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#: 2808741, YIELD: 17, DELIVERED: 16, SCRAPPED: 1. REASON FOR SCRAPPING: DROPPED ON FLOOR. 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: LOOSENING AND STEM SUBSIDENCE. EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS A REVISION DUE TO LOOSENING (ASEPTIC STEM LOOSENING). REVIEW OF RECEIVED DATA: AS LISTED ON THE FIRST PAGE OF THIS REPORT, VARIOUS DOCUMENTS WERE RECEIVED IN GERMAN LANGUAGE. ALL DOCUMENTS WERE REVIEWED, TRANSLATED TO ENGLISH AND THE INFORMATION RELEVANT TO THE INVESTIGATION IS SUMMARIZED BELOW. SWISSMEDIC VIGILANCE REPORT. THE (B)(6) BALGRIST REPORTED THE CASE TO THE COMPETENT AUTHORITY ON (B)(6) 2018. THE FOLLOWING IS STATED IN THE EVENT DESCRIPTION SECTION. IN OCTOBER 2014 THE PATIENT RECEIVED A TOTAL HIP PROSTHESIS (THP) ON THE LEFT SIDE IN TICINO. IN OCTOBER 2015 AT HUG (GENEVA) A REVISION DUE TO A LOW-GRADE INFECTION WAS PERFORMED RESULTING IN A GIRDLESTONE SITUATION AND A RE-IMPLANTATION WAS MADE IN JANUARY 2016. ON THE X-RAYS TAKEN ONE WEEK AFTER REVISION A SUBSIDENCE OF THE STEM COULD ALREADY BE SEEN. THE LATTER PROGRESSED OVER THE TIME MORE AND MORE AND THE PATIENT¿S SUFFERING INCREASED. AFTER EXCLUSION OF AN INFECTION BY MEANS OF A JOINT PUNCTURE, THE STEM, INLAY AND HEAD WERE REVISED ON (B)(6) 2018. COMMENT OF THE AUTHOR: THE REVISION SURGERY REPORT STATES ON (B)(6) 2018 AS THE REVISION DATE. CONSULTATION REPORT ON (B)(6) 2018, (B)(6) BALGRIST. ON TOP OF THE FIRST PAGE OF THE REPORT THE PATIENT¿S HEIGHT AND WEIGHT ARE HANDWRITTEN NEXT TO THE DATE ON (B)(6) 2018. THIS INFORMATION IS FILLED IN ON THE FIRST PAGE OF THIS REPORT. DIAGNOSIS: SUBSIDENCE OF THE STEM WITH PERFORATION OF THE ANTERIOR FEMORAL CORTICAL BONE ON THE LEFT SIDE AT STATE AFTER: RE-IMPLANTATION OF LEFT THP USING A POSTERIOR APPROACH (FITMORE 56, REVITAN 65-18-260, 36 L) ON (B)(6) 2016 (HUG) REVISION DUE TO A LOW-GRADE INFECTION RESULTING IN A GIRDLESTONE SITUATION IN OCTOBER 2015 (HUG). IMPLANTATION OF A THP IN THE LEFT HIP IN OCTOBER 2014 (TICINO). ANAMNESIS: FOR SEVERAL MONTHS THERE IS PAIN IN THE AREA OF THE LEFT THIGH, LATERAL AND ANTERIOR DURING WEIGHT BEARING. TO RULE OUT ANOTHER LOW-GRADE INFECTION AN ANTI-GRANULOCYTE SCINTIGRAPHY WITH SPECT-CT WAS PERFORMED IN MAY THIS YEAR. THIS SHOWED NO EVIDENCE OF A LOW-GRADE INFECTION. THE PATIENT DOES NOT COMPLAIN OF FEVER OR CHILLS. FINDINGS: THE PATIENT USES TWO WALKING STICKS AND HAS A 1 CM INCREASE OF THE LEFT SHOE SOLE. WITHOUT THE WALKING STICKS THE PATIENT CAN BARELY PUT LOAD ON THE LEFT LEG. STANDING ON ONE LEG IS NOT POSSIBLE AND THUS THE TRENDELENBURG'S TEST CANNOT BE PERFORMED. STANDING ON TIPTOES AND HEELS IS POSSIBLE ONLY WITH SUPPORT. THE SCAR ON THE LEFT THIGH IS INCONSPICUOUS. THERE IS TENDERNESS ON PALPATION IN THE AREA OF THE GROIN AS WELL AS ANTERIORLY IN THE MIDDLE PART OF THE FEMUR. THERE IS SIGNIFICANT SHORTENING OF THE LEFT LEG. THERE IS TENDERNESS ON PALPATION ABOVE THE TROCHANTER. ADDITIONAL INVESTIGATIONS: AP AND SECOND VIEW X-RAYS OF THE ENTIRE LEFT FEMUR, PELVIS OVERVIEW AND AXIAL VIEW OF THE LEFT HIP FROM ON (B)(6) 2018: COMPARED WITH THE PREVIOUS X-RAYS THERE IS A PROGRESSING SUBSIDENCE OF THE REVITAN STEM WITH PERFORATION OF THE ANTERIOR FEMORAL CORTEX BY THE STEM¿S TIP. ASSESSMENT AND PROCEDURE: WITH PROGRESSING SUBSIDENCE OF THE STEM WITH PERFORATION OF THE DISTAL FEMORAL CORTEX THERE IS A NEED FOR REVISION OF THE STEM. PRIOR TO REVISION ANOTHER LOW-GRADE INFECTION SHOULD BE EXCLUDED BY PERFORMING A PUNCTURE AND BLOOD TESTS. THESE WILL BE PERFORMED AS SOON AS POSSIBLE AND THE PATIENT WILL BE SEEN AGAIN IN TWO WEEKS. IF THERE ARE NO SIGNS OF AN INFECTION, A REVISION OF THE STEM POSSIBLY WITH OSTEOSYNTHESIS OF THE DISTAL FEMUR WOULD BE PLANNED. CONSULTATION REPORT ON (B)(6) 2018, (B)(6) BALGRIST. DIAGNOSIS: THE REPORT SHOWS THE SAME DIAGNOSIS AS THE PREVIOUS CONSULTATION REPORT ON (B)(6) 2018 WITH AN ADDITION OF STAPHYLOCOCCUS EPIDERMIDIS FOR THE LOW-GRADE INFECTION RESULTING IN A GIRDLESTONE SITUATION IN OCTOBER 2015 (HUG). ANAMNESIS: THE PATIENT PRESENTS FOR THE FOLLOW-UP AFTER INFECTION CHECK-UP. ON THE LEFT SIDE, THE PAIN IS STILL STRONG IN THE THIGH AND RADIATES TO THE KNEE. FOR THIS REASON THE PATIENT NEEDS A WALKING STICK. FINDINGS: UNCHANGED TO PREVIOUS EXAMINATION. ADDITIONAL INVESTIGATIONS: PUNCTURE OF THE LEFT HIP FROM ON (B)(6) 2018: NO GROWTH OF BACTERIA. ASSESSMENT AND PROCEDURE: AN INFECTION COULD BE EXCLUDED AT LEAST WITH HIGH PROBABILITY. IT SHOULD BE NOTED, HOWEVER, THAT THE PATIENT ALSO HAD NORMAL BLOOD VALUES DURING THE HOSPITALIZATION IN GENEVA. BASED ON THE SPECTRUM OF GERMS A ONE STAGE REVISION WILL BE PERFORMED. THE OPERATION IS PLANNED FOR THE ON (B)(6) 2018. REVISION REPORT ON (B)(6) 2018. DIAGNOSIS: ASEPTIC LOOSENING OF THE LEFT HIP STEM WITH: PERFORATION OF THE ANTERIOR FEMORAL CORTICAL BONE STATE AFTER RE-IMPLANTATION OF LEFT THP VIA A POSTERIOR APPROACH (FITMORE 56, REVITAN 65-18-260, 36L) ON (B)(6) 2016 (HUG); AT REVISION DUE TO A LOW-GRADE INFECTION RESULTING IN A GIRDLESTONE SITUATION IN OCTOBER 2014 (HUG). STATE AFTER IMPLANTATION OF A THP IN THE LEFT HIP IN OCTOBER 2014 (TICINO). INDICATION: THERE IS AN ASEPTIC LOOSENING OF THE STEM. A SEPTIC OCCURRENCE WAS EXCLUDED TO THE EXTENT POSSIBLE. THE STEM SUBSIDED AND PERFORATED THE ANTERIOR FEMORAL CORTEX NEAR THE KNEE. THERE IS PERSISTENT SEVERE SUFFERING. THE INDICATION FOR REVISION OF THE STEM IS GIVEN. PROCEDURE: THE HIP IS OPENED THROUGH THE OLD INCISION. AT OPENING OF THE JOINT SEROUS LIQUID DRAINS. TROCHANTER OSTEOTOMY IS MADE ACCORDING TO PLANNING. THE STEM CAN BE REMOVED BY HAND. TWO DISTAL CERCLAGES ARE PLACED TO SECURE THE FEMUR. THE LATTER IS CURETTED AND TISSUE SAMPLES ARE SENT FOR BACTERIOLOGICAL AND HISTOLOGICAL EXAMINATION. THE ACETABULUM IS EXPOSED AND THE INLAY IS REMOVED. EXTENSIVE RINSING IS CONDUCTED AND THE FEMORAL CANAL IS PREPARED TO PLACE A REEF STEM. THE FURTHER STEPS IN THE SURGICAL REPORT DESCRIBE THE IMPLANTATION OF A REEF STEM (FIXED WITH 2 SCREWS), A DURASUL INSERT AND A HEAD SIZE 36XL. DISCHARGE REPORT ON (B)(6) 2018: THE REPORT STATES THAT THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2018. EXCEPT FOR THE INFORMATION ALREADY MENTIONED IN THE REPORTS ABOVE THE DISCHARGE REPORT DOES NOT CONTAIN ADDITIONAL INFORMATION RELEVANT FOR THE INVESTIGATION. X-RAYS: ACCORDING TO THE INFORMATION ON THE CD THE X-RAYS WERE TAKEN IN LYING POSITION. X-RAYS TAKEN ON (B)(6) 2018. A PELVIS OVERVIEW, AN AP VIEW AND TWO SECOND VIEWS OF THE LEFT HIP ARE AT HAND. ON THE PELVIS OVERVIEW AND ONE SECOND VIEW THE DISTAL PART OF THE STEM IS NOT VISIBLE. THE PELVIS OVERVIEW EXHIBITS A REVITAN STEM IMPLANTED IN THE LEFT HIP. IN THIS VIEW TWO CERCLAGES ARE VISIBLE AROUND THE DIAPHYSIS AREA OF THE FEMUR. THE STEM IS LOCATED VERY DISTALLY IN THE FEMUR SO THAT THE STEM¿S NECK IS COMPLETELY SURROUNDED BY BONE. THE REVITAN STEM IS NOT CENTERED IN THE MIDDLE OF THE MEDULLARY CANAL. ALONG THE MEDIAL SIDE OF THE STEM A RADIOLUCENT AREA IS NOTICEABLE BETWEEN THE STEM AND THE CORTICAL BONE. ON THE SECOND VIEW THERE ARE THREE CERCLAGES NOTICEABLE. RADIOLUCENT AREAS ARE VISIBLE AROUND THE STEM AND SOME OF THOSE AREAS ARE BORDERED BY A SCLEROTIC LINE ON THE BONE SIDE. ON THE AP AND ONE SECOND VIEW OF THE LEFT HIP THE STEM IS COMPLETELY VISIBLE. BOTH VIEWS SHOW THAT THE TIP OF THE DISTAL PART OF THE REVITAN STEM IS LOCATED CLOSE TO THE KNEE JOINT. ON THE AP VIEW THE TIP OF THE STEM IS POSITIONED NEAR THE CENTER OF THE LATERAL KNEE CONDYLE. THE MOST DISTAL CERCLAGE SEEMS TO BE OVERGROWN BY BONE ON THE LATERAL SIDE. ON THE SECOND VIEW IT CAN BE OBSERVED THAT THE TIP OF THE STEM PERFORATES THE ANTERIOR CORTICAL BONE CLOSE TO THE KNEE JOINT. THERE IS A RADIOLUCENT AREA VISIBLE ALONG THE POSTEROMEDIAL SIDE OF THE REVITAN STEM AS WELL AS ALONG ITS ANTEROLATERAL SIDE IN THE DISTAL REGION. THE MOST DISTAL CERCLAGE SEEMS TO BE OVERGROWN BY BONE ON THE ANTERIOR SIDE. X-RAYS TAKEN ON (B)(6) 2018. THESE X-RAYS SHOW THE SITUATION AFTER THE REVISION OF THE REVITAN STEM. DEVICES ANALYSIS: VISUAL EXAMINATION: THE PROXIMAL PART OF THE REVITAN STEM IS STILL ASSEMBLED TO THE DISTAL PART OF THE STEM IN A 40° ANTETORSION. THE REVITAN STEM SHOWS REVISION DAMAGE IN THE FORM OF SCRATCHES AND NICKS ON ITS PROXIMAL PART AND PARTIALLY ON THE PROXIMAL PORTION OF THE DISTAL PART. ON THE TAPER, NECK AND SHOULDER REGION OF THE PROXIMAL STEM PART THERE ARE SOME COLORED SPOTS AND LINES VISIBLE. THERE ARE NO SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE OF THE PROXIMAL AND DISTAL PART OF THE STEM. IN THE PROXIMAL REGION OF THE DISTAL STEM PART A WHITISH AREA CAN BE OBSERVED ON THE ANTERIOR SIDE. THIS AREA WAS INSPECTED WITH A LOW POWER MICROSCOPE TYPE WILD M38 (EQ-ID: WNT-03-RSR-540-161187) AND SHOWED PARTICLES OF BONE ATTACHED TO THE STEM SURFACE, PROBABLY DERIVING FROM THE REMOVAL OF THE STEM. ON THE NECK REGION OF THE PROXIMAL STEM PART A POLISHED AREA CAN BE SEEN ON THE POSTEROMEDIAL SIDE. ON THE MEDIAL SIDE OF THE PROXIMAL STEM PART A POLISHED AREA CAN BE OBSERVED. FURTHER, ON THE DISTAL PART OF THE STEM, SEVERAL POLISHED AREAS CAN BE DETECTED ALONG THE FINS. THE TIP OF THE STEM IS SHINY POLISHED. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: THE REVITAN STEM WAS REVISED AFTER 2 YEARS AND 9 MONTHS IN VIVO DUE TO ASEPTIC LOOSENING AND SUBSIDENCE. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT HAD A THP ON THE LEFT SIDE IN OCTOBER 2014. ONE YEAR LATER A REVISION DUE TO A LOW-GRADE INFECTION WAS PERFORMED RESULTING IN A GIRDLESTONE SITUATION AND A REVITAN STEM WAS IMPLANTED IN JANUARY 2016. ACCORDING TO THE SWISSMEDIC VIGILANCE REPORT, THE X-RAYS TAKEN ONE WEEK AFTER IMPLANTATION SHOWED ALREADY A SUBSIDENCE OF THE STEM. THE CONSULTATION REPORT ON (B)(6) 2018 STATES THAT AN X-RAY CHECK WAS MADE AND COMPARED WITH THE PREVIOUS X-RAYS THERE IS A PROGRESSING SUBSIDENCE OF THE REVITAN STEM WITH PERFORATION OF THE ANTERIOR FEMORAL CORTEX BY THE STEM¿S TIP. AFTER EXCLUSION OF AN INFECTION A REVISION SURGERY WAS MADE IN OCTOBER 2018. THE REVISION REPORT STATES THAT THE REVITAN STEM CAN BE REMOVED BY HAND. THERE ARE X-RAYS AT HAND ONLY FROM BEFORE AND AFTER REVISION OF THE REVITAN STEM. THE STEM IS NOT CENTERED IN THE MEDULLARY CANAL AND IS LOCATED VERY DISTALLY IN THE FEMUR SO THAT THE STEM¿S NECK IS COMPLETELY SURROUNDED BY BONE AND THE TIP OF THE STEM PERFORATES THE ANTERIOR CORTICAL BONE. RADIOLUCENT AREAS ARE VISIBLE AROUND THE STEM AND SOME OF THOSE AREAS ARE BORDERED BY A SCLEROTIC LINE ON THE BONE SIDE. VISUAL EXAMINATION OF THE STEM SHOWED NO SIGNS OF BONE ATTACHMENTS ON ITS ANCHORING SURFACE. SIGNS OF LOOSENING IN THE FORM OF POLISHED AREAS COULD BE OBSERVED BOTH ON THE PROXIMAL AND DISTAL PART OF THE STEM. THE OBSERVATIONS MADE FROM EVALUATING THE X-RAYS AND THE APPEARANCE OF THE RETRIEVAL ARE IN ALIGNMENT WITH THE SURGICAL REPORT OF REVISION, AND INDICATE LOOSENING AND SUBSIDENCE OF THE STEM. AS THERE IS NO INFORMATION AT HAND FROM BEFORE AND IMMEDIATELY AFTER THE IMPLANTATION OF THE REVITAN STEM IT STAYS UNKNOWN WHY IT CAME TO THE LOOSENING AND SUBSIDENCE OF THE STEM. IT CAN ONLY BE HYPOTHESIZED THAT THE STEM DID NOT HAVE SUFFICIENT PRIMARY STABILITY AND SUBSIDED SHORTLY AFTER IMPLANTATION. THE SUBSIDENCE OF THE STEM MOST PROBABLY PROGRESSED OVER TIME AND LED TO THE PERFORATION OF THE ANTERIOR CORTICAL BONE JUST ABOVE THE KNEE. THE COLORED SPOTS AND LINES OBSERVED ON THE PROXIMAL PART OF THE REVITAN STEM CAN MOST PROBABLY BE ATTRIBUTED TO THE USE OF AN ELECTROCAUTERY INSTRUMENT DURING SURGERY. 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 - 01142 - 1

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE - DETAIL OF PRODUCT: ITEM # UNKNOWN, ITEM NAME REVITAN PROXIMAL STEM HIP , LOT # UNKNOWN; ITEM # UNKNOWN, ITEM NAME BIOLOX OPTION HEAD HIP , LOT # UNKNOWN; ITEM # UNKNOWN, ITEM NAME METASUL INLAY HIP, LOT # UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904130 REVITAN DIST. STRAIGHT 18/260 ZIMMER POROLOCK MIS STEM KWA ZIMMER GMBH N/A 2612589

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R