BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140

    MDR report key: 10513608 · Received September 10, 2020

    Report

    Report Number
    0009613350-2020-00401
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 26, 2020
    Report Date
    February 10, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. D11: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED; ITEM: 01.00401.075; LOT: 2902113. EVENT DESCRIPTION: ACCORDING TO THE RECEIVED INFORMATION THE PATIENT HAD A PRIMARY RIGHT HIP REPLACEMENT IN (B)(6) 2006. THIS PROSTHESIS WAS REVISED IN (B)(6) 2008 DUE TO AN INFECTION. A ONE-STAGE REVISION WAS PERFORMED AND A REVITAN STEM WAS IMPLANTED WITH A ZIMMER PRESS-FIT CUP AND A METASUL PAIRING. DUE TO AN ELEVATED METAL ION LEVEL REVISION SURGERY WAS PERFORMED IN (B)(6) 2014 AND THE PROXIMAL PART OF THE REVITAN STEM WAS REVISED TOGETHER WITH THE PRESS-FIT CUP AND THE METASUL PAIRING (SEE (B)(4). A LONGER REVITAN PROXIMAL PART (65 MM COMPARED WITH THE PREVIOUS 55 MM) WAS IMPLANTED TOGETHER WITH A DURASUL HEAD (ZIMMER BIOMET PRODUCTS) AND A SATURNE DUAL MOBILITY CUP AND INSERT (AMPLITUDE PRODUCTS). IN (B)(6) 2018 THE PATIENT UNDERWENT ANOTHER REVISION DUE TO A FRACTURE OF THE PROXIMAL PART OF THE REVITAN STEM (SEE (B)(4). ACCORDING TO THE REVISION REPORT, A NEW REVITAN PROXIMAL PART WITH A SIZE OF 85 MM WAS IMPLANTED AS THE PATIENT STILL HAD A LEG LENGTH DIFFERENCE OF 2 CM. A COCR HEAD AND A SATURNE INSERT WERE IMPLANTED AS WELL. AN ANSM REPORT OF 01 (B)(6) 2020 INFORMS THAT THE REVITAN STEM (DISTAL PART IMPLANTED IN (B)(6) 2008 AND PROXIMAL PART CHANGED IN (B)(6) 2018) WAS REVISED IN (B)(6) 2020 DUE TO A BREAKAGE OF THE DISTAL PART (EVENT COVERED IN THIS COMPLAINT). REVIEW OF RECEIVED DATA: SURGICAL REPORT DATED (B)(6) 2008: INDICATION: THE PATIENT HAS A CHRONIC PROPIONIBACTERIUM ACNES SEPSIS ON A TOTAL HIP ARTHROPLASTY PERFORMED IN (B)(6) 2006. IN (B)(6) 2007 THE PATIENT HAD A RINSE AND WAS PUT UNDER INTRAVENOUS ANTIBIOTIC THERAPY FOR SEVERAL MONTHS. WHEN THE ANTIBIOTICS WERE STOPPED, THERE WAS AN IMMEDIATE RECURRENCE WITH PAIN, JOINT EFFUSION AND ELEVATION OF THE CRP LEVEL. IT WAS THEREFORE DECIDED TO CARRY OUT A ONE-STEP REVISION OF THE TOTAL HIP ARTHROPLASTY. PROCEDURE: THE HIP JOINT IS OPENED. A YELLOWISH, SLIGHTLY CLOUDY LIQUID DRAINS AND BACTERIOLOGICAL SAMPLES ARE TAKEN. A CAPSULECTOMY AND A SYNOVECTOMY AS LARGE AS POSSIBLE ARE PERFORMED. THE JOINT IS DISLOCATED AND THE HEAD IS REMOVED. AGAIN, AS IN THE PRIMARY IMPLANTATION AND AS VISIBLE ON THE PRE-OPERATIVE X-RAYS, THERE IS A LYSIS CAVITY AROUND THE METAPHYSEAL PART SUPERIOR OF THE DIAPHYSIS. ATTEMPTS TO REMOVE THE STEM ARE UNSUCCESSFUL. THE STEM IS COVERED WITH HYDROXYAPATITE ALONG ITS ENTIRE LENGTH. IT IS THEREFORE DECIDED TO PERFORM A 15 CM FEMUR OSTEOTOMY STOPPING 2 CM ABOVE THE END OF THE STEM. THE SAW IS USED FLUSH WITH THE PROSTHESIS, WHICH ALLOWS GETTING A GOOD FEMORAL FLAP QUALITY. THE RELEASE OF THE STEM IS THEN COMPLETED WITH SMALL OSTEOTOMES. THE DISTAL PART OF THE STEM WAS PERFECTLY FIXED. THE STEM IS REMOVED USING THE EXTRACTOR. SAMPLES ARE TAKEN AND SENT FOR BACTERIOLOGICAL ANALYSIS. MOVING TO THE ACETABULUM, USING CURVED CHISELS THE CUP CAN BE REMOVED WITHOUT ANY DAMAGE. SAMPLES ARE TAKEN FOR BACTERIOLOGICAL ANALYSIS. A SYNOVECTOMY AS LARGE AS POSSIBLE IS PERFORMED. ALL POTENTIAL SEPTIC TISSUE IS RESECTED. IN FRONT OF THE JOINT, A SMALL PALPABLE POCKET UNDER THE SKIN IS CURETTED. THE INSTRUMENTS ARE CHANGED. THE ACETABULUM IS PREPARED WITH A 58 THEN 60 MM DIAMETER REAMER. THE TRIAL IMPLANT HAS GOOD STABILITY. A ZIMMER PRESS-FIT CUP WITH A DIAMETER OF 60 MM IS INSERTED. THE STABILITY IS VERY GOOD. A METASUL INSERT SIZE 50/32 IS PLACED. MOVING TO THE FEMUR, THE DIAPHYSIS IS PREPARED WITH THE REVITAN INSTRUMENT SET. A DISTAL TRIAL STEM SIZE 18/140 WITH A PROXIMAL PART SIZE 65 MM IS PLACED. THE HIP IS REDUCED AND A SURPLUS OF LENGTH IS OBSERVED. THUS, A PROXIMAL PART OF 55 MM WITH A M/0 HEAD ARE PLACED. THERE IS A SATISFACTORY LENGTH WITH A RELATIVELY STABLE SITUATION. THE TRIAL IMPLANTS ARE REMOVED. A DEFINITIVE DISTAL PART SIZE 18/140 IS PLACED FOLLOWED BY A PROXIMAL PART SIZE 55 MM WITH AN ANTEVERSION OF APPROXIMATELY 15°. A NEW ATTEMPT IS MADE WITH A M/0 HEAD. THERE IS A SLIGHT POSTERIOR INSTABILITY IN FLEXION. A DEFINITIVE METASUL HEAD 32L/+4 IS PLACED. THE FEMORAL FLAP IS REPOSITIONED AND SECURED WITH 3 CERCLAGES. THE HIP IS REDUCED AND FOUND TO BE STABLE. ABUNDANT RINSING WITH SERUM IS DONE, REDON DRAINAGE IS PLACED AND THE WOUND IS CLOSED. MEDICAL LETTER OF (B)(6) 2014, DR. (B)(6) TO DR. (B)(6). THE PATIENT WAS SEEN IN CONSULTATION TO DISCUSS THE RESULTS OF HIS VARIOUS EXAMINATIONS. THE LETTER STATES THAT THE PATIENT¿S BLOOD TESTS CONFIRM THE EXISTENCE OF A HIGH LEVEL OF COBALT AND ALSO CHROMIUM THUS CONFIRMING WEAR PROBLEMS AT THE METAL-ON-METAL INTERFACE EXPLAINING BOTH THE EFFUSION AND THE PAIN IN THE HIP. THERE IS PROBABLY NO ARGUMENT IN FAVOR OF AN INFECTIOUS RECURRENCE. REVISION OF THE HIP ARTHROPLASTY IS NECESSARY TO AVOID ANY DAMAGE TO THE HIP AND ESPECIALLY THE RISK OF PROGRESSIVE LOOSENING OF THE PROSTHETIC PARTS. IT IS THEREFORE SUGGESTED TO NOT ONLY REVISE THE ACETABULAR CUP BUT ALSO THE PROXIMAL PART OF THE STEM. THIS WILL ALSO ALLOW RESTORING THE DIFFERENCE IN LENGTH PRESENT AT THE PATIENT¿S RIGHT LEG, WHICH IS SHORTER. IMPLANTS REPORT OF (B)(6) 2014: THE REPORT CONTAINS A TABLE WITH INFORMATION ABOUT THE IMPLANTS, BONE ALLOGRAFT AND INSTRUMENTS USED DURING THE REVISION SURGERY OF (B)(6) 2014. THE IMPLANTS ARE SHOWN IN TABLE 1. HOSPITALIZATION REPORT OF (B)(6) 2014: THE PATIENT WAS ADMITTED IN THE HOSPITAL ON (B)(6) 2014 AND DISCHARGED ON (B)(6) 2014. A REVISION OF THE RIGHT HIP PROSTHESIS WITH CHANGE OF THE PROXIMAL PART OF THE MODULAR STEM AND THE ACETABULAR CUP WAS PERFORMED. THE REPORT MENTIONS THAT THE EARLY POSTOPERATIVE RESULTS WERE RATHER FAVORABLE. REVISION REPORT OF (B)(6) 2018: INDICATION: FRACTURE OF THE PROXIMAL PART OF A REVITAN TOTAL HIP PROSTHESIS IMPLANTED IN 2006 IN A PATIENT WITH A HISTORY OF SEPSIS AFTER A PRIMARY TOTAL HIP REPLACEMENT. X-RAYS CLEARLY SHOW A FRACTURE OF THE BASE OF THE PROXIMAL PART WHICH IS MISALIGNED HAVING A METAL FRAGMENT. THEREFORE IT IS DECIDED TO CARRY OUT A REVISION. PROCEDURE: REOPENING AT THE UPPER PART OF THE INITIAL INCISION. A BLACKISH POCKET IS RAPIDLY OBSERVED WHICH IS OPENED. IT CONTAINS A BLACK LIQUID THAT IS ASPIRATED. SAMPLES ARE TAKEN FOR BACTERIOLOGICAL ANALYSIS. IT IS POSSIBLE TO LOCATE THIS POCKET OF ARTICULAR SYNOVITIS WHICH IS GRADUALLY DISSECTED AND REMOVED. THE JOINT IS EXPOSED WHICH SHOWS SYNOVITIS AND BLACK METALLOSIS. THE PROSTHESIS IS DISLOCATED AND THE HEAD AND THE CUP¿S INSERT ARE REMOVED. IT IS NOTICED THAT THE LOCKING MECHANISM BETWEEN THE PROXIMAL AND DISTAL PART IS PARTIALLY BROKEN. THE PROXIMAL PART IS REPOSITIONED AND THE NUT IS REMOVED. THE PROXIMAL PART IS REMOVED. IT IS FRACTURED AT A PART OF ITS BASE WITH SEVERAL FRACTURE FRAGMENTS AND WORN INTERNALLY WHICH EXPLAINS THE AMOUNT OF METALLOSIS. THE BONE, WHICH IS STAINED WITH TITANIUM METAL DEBRIS, IS THOROUGHLY CLEANED. NOW THE TAPER OF THE DISTAL PART OF THE STEM CAN BE INSPECTED AND FOUND TO BE IN GOOD CONDITION. IT IS THEREFORE DECIDED TO KEEP IT. A REDUCTION IS MADE USING A TRIAL PROXIMAL PART SIZE 85 MM WITH A HEAD AND A TRIAL SATURNE INSERT. THE PATIENT HAD A LEG LENGTH DIFFERENCE OF ABOUT 2 CM. THE PREVIOUS PROXIMAL PART WAS 65 MM. THE REDUCTION IS SLIGHTLY DIFFICULT. IT COULD BE REALIZED SATISFACTORILY WITH A LITTLE TENSION ON THE PERI-ARTICULAR SOFT TISSUE. THE LENGTH CHECK IS GOOD. THE TRIAL PART IS REMOVED AND THE DEFINITE 85 MM REVITAN PROXIMAL PART IS PLACED AND IMPACTED. A GOOD IMPACTION OF THE PROXIMAL PART CAN BE CONFIRMED AND IT IS THEN LOCKED WITH THE NUT AND THE TORQUE WRENCH. CARE IS TAKEN TO OBTAIN AN ANTEVERSION OF 15° - 20° AS PREVIOUSLY IT WAS SLIGHTLY LIMITED. ABUNDANT RINSING WITH SERUM IS MADE AND A 28 MM COCR HEAD AND AN AMPLITUDE SATURNE INSERT ARE PLACED. THE JOINT IS REDUCED, RINSED, A REDON IS PLACED AND THE WOUND IS CLOSED. ANSM REPORT OF (B)(6) 2018: THE REPORT DOES NOT CONTAIN NEW INFORMATION RELEVANT FOR THE INVESTIGATION. EMAIL FROM FRANCE SUBSIDIARY OF 29 JUNE 2018: THE EMAIL INFORMS ABOUT THE HEIGHT AND WEIGHT OF THE PATIENT FILLED IN ON THE FIRST PAGE OF THIS REPORT. IT IS ALSO MENTIONED THAT THERE WERE NO PARTICULAR CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE FRACTURE OF THE PROXIMAL PART. ANSM REPORT OF (B)(6) 2020: UNDER THE (DESCRIPTION OF THE FACTS) SECTION OF THE REPORT IT IS MENTIONED THAT THERE IS A BREAKAGE OF THE DISTAL PART OF THE REVITAN STEM, PLACED ON (B)(6) 2008 AND REVISED ON (B)(6) 2018 DUE TO A FRACTURE OF THE PROXIMAL PART THAT WAS CHANGED. UNDER THE (CLINICAL IMPACT) SECTION IT IS STATED THAT THE PATIENT HAS PAIN AND A MAJOR FUNCTIONAL DISABILITY. DURING REVISION SURGERY, DIFFUSE METALLOSIS WITH EFFUSION WAS FOUND. X-RAYS AN UNDATED AP X-RAY OF THE RIGHT HIP WAS RECEIVED. IT SHOWS A REVITAN STEM IMPLANTED IN THE RIGHT HIP WITH A DUAL MOBILITY CUP. THE PROXIMAL PART OF THE REVITAN STEM IS TIPPED MEDIALLY AND ITS DISTAL END IS SHIFTED LATERALLY. MEDIALLY, AT THE DISTAL END A FRACTURE FRAGMENT CAN BE SEEN. A RADIOLUCENT GAP CAN BE RECOGNIZED BETWEEN THE CORTICAL BONE AND THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART WHICH EXTENDS SLIGHTLY TO THE PROXIMAL REGION OF THE DISTAL STEM PART. THE GAP IS PARTIALLY BORDERED ON THE BONE SIDE BY A SCLEROTIC LINE. THERE ARE THREE CERCLAGE WIRES AROUND THE FEMUR. PRODUCT EVALUATION: THIS REPORT COVERS THE INVESTIGATION OF THE DISTAL PART OF THE REVITAN STEM, IMPLANTED ON (B)(6) 2008, AND THE PROXIMAL PART OF THE REVITAN STEM, IMPLANTED ON (B)(6) 2018, WHICH WERE REVISED ON (B)(6) 2020. THE INVESTIGATION OF THE ZIMMER BIOMET IMPLANTS REVISED ON (B)(6) 2014 AND (B)(6) 2018 WAS COVERED IN (B)(4), RESPECTIVELY. FOR BOTH CASES A NO-PRODUCT INVESTIGATION WAS PERFORMED AS THE PARTS WERE NOT RECEIVED. VISUAL EXAMINATION: THE REVITAN STEM WAS RECEIVED DISCONNECTED AT THE CONNECTION BETWEEN THE CONNECTION PIN AND THE DISTAL STEM BODY. THE LATTER SHOWS A CIRCUMFERENTIAL FRACTURE APPROXIMATELY 20 MM FROM ITS FACE SURFACE. THE PROXIMAL PART OF THE REVITAN STEM AND THE CONNECTION PIN WERE STILL ASSEMBLED. ON THE PROXIMAL PART OF THE STEM, REVISION DAMAGE IN THE FORM OF SCRATCHES AND NICKS CAN BE SEEN ON THE TAPER, NECK AND ANCHORING SURFACE. ON THE POSTEROLATERAL SIDE OF THE STEM¿S NECK AS WELL AS ON THE STEM¿S ANCHORING SURFACE SEVERAL SPOTS FROM THE USE OF AN ELECTROCAUTERY TOOL DURING SURGERY ARE RECOGNIZABLE. THE TAPER¿S FACE SURFACE IS DARK DISCOLORED. IN THE PROXIMAL REGION OF THE TAPER A CIRCUMFERENTIAL DARK LINE CAN BE SEEN. ON THE MEDIAL SIDE OF THE STEM¿S NECK THERE IS A STRIPE CONSISTING OF POLISHED HORIZONTAL LINES. THERE ARE NO SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE OF THE PROXIMAL STEM PART. SOME HORIZONTAL POLISHED LINES CAN BE RECOGNIZED ON THE DISTAL HALF OF THE MEDIAL SIDE OF THE ANCHORING SURFACE. FURTHER A SMALL POLISHED AREA IS VISIBLE ON THE LATERAL SIDE AT THE DISTAL END OF THE ANCHORING SURFACE. THE DISTAL FACE SURFACE OF THE PROXIMAL PART IS POLISHED ON THE ANTERIOR, POSTERIOR AND MEDIAL SIDE. ITS MEDIAL SHOULDER IS WORN SO THAT THE SURFACE HAS AN APPROXIMATELY 45° ANGLE. THERE IS ALSO A POLISHED AREA ON THE POSTEROMEDIAL SIDE OF THE BLASTED SURFACE OF THE CONNECTION PIN. THE PRESS-FIT REGION OF THE CONNECTION PIN IS NOT ANYMORE IN ITS ORIGINAL CONDITION AND SHOWS A MIXTURE OF POLISHING, SMEARING, FRETTING AND CORROSION. SEVERAL CRACKS CAN BE SEEN ON THE POSTERIOR SIDE OF THE PRESS-FIT REGION. THE ANTERIOR SIDE OF THE DISTAL CONICAL REGION OF THE PIN EXHIBITS POLISHING, SMEARING AND AN ELLIPTICAL SHAPED GROOVE. BETWEEN THE SMEARED AND POLISHED AREA A PERPENDICULAR LINE IS VISIBLE. THE DISTAL PART OF THE REVITAN STEM IS FRACTURED CIRCUMFERENTIALLY APPROXIMATELY 20 MM BELOW ITS FACE SURFACE. THE ANTERIOR AND POSTERIOR SHOULDER AND THE MEDIAL FACE SURFACE OF THE PROXIMAL FRACTURE PART ARE WORN. THE ANCHORING SURFACE OF THE PROXIMAL FRACTURE PART SHOWS SOME BONE ATTACHMENTS AS WELL AS SOME SLIGHT POLISHED AREAS. THE INNER SIDE OF THE PROXIMAL FRACTURE PART IS WORN MEDIAL-PROXIMAL AND LATERAL-DISTAL SO THAT THE MATERIAL THICKNESS IS CLEARLY DIMINISHED. THE FRACTURE ORIGINATED IN THIS AREA WITH THE DIMINISHED MATERIAL THICKNESS FROM THE OUTSIDE TO THE INSIDE AND CONTINUES TO BOTH SIDES ALONG THE CIRCUMFERENCE. THE PROXIMAL FRACTURE SURFACE SHOWS SOME PARTIALLY POLISHED SPOTS AND A SHINY POLISHED AREA AT THE MEDIAL END. ON THE DISTAL FRACTURE SURFACE THERE ARE MORE POLISHED ZONES THAN ON THE PROXIMAL ONE AND SOME DEFORMATION. THE PROXIMAL FRACTURE SURFACE WAS INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE (SEM) TYPE JEOL JSM-6610. MOST OF THE FRACTURE STRUCTURE IS FLAT AND FEATURELESS, HOWEVER IN SOME REGIONS A STRUCTURE THAT POINTS TO FATIGUE COULD BE RECOGNIZED. SIGNS OF A RESIDUAL FRACTURE WERE NOT SEEN. NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACE. THE DISTAL FRACTURE PART EXHIBITS A NEW LEDGE ON THE INSIDE LOCATED LATERALLY WHERE THE MATERIAL THICKNESS IS DIMINISHED. ON THE FINNED REGION OF THE DISTAL FRACTURE PART BONE ATTACHMENTS AND REVISION DAMAGE IN THE FORM OF SCRATCHES, NICKS AND DRILL MARKS ARE OBSERVABLE. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION OF THE PROXIMAL AND DISTAL REVITAN STEM WAS APPROVED BY ZIMMER BIOMET. THE PRODUCT IDENTIFICATION OF THE COCR HEAD IMPLANTED IN 2018 REMAINS UNKNONW. THEREFORE, COMPATIBILITY CANNOT BE ASSESSED. THE SATURNE DUAL MOBILITY CUP AND INSERT (AMPLITUDE PRODUCTS) IS A COMPETITOR'S PRODUCT. AS COMBINATION OF PRODUCTS FROM DIFFERENT MANUFACTURERS WAS USED THIS HAS TO BE CONSIDERED OFF-LABEL USE. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. RAW MATERIAL CERTIFICATE: REVIEW OF THE RAW MATERIAL CERTIFICATE SHOWED THAT THERE WAS A CONCESSION DUE TO DEVIATION IN MATERIAL¿S MICROSTRUCTURE. INVESTIGATION FROM THE MATERIAL RESEARCH DEPARTMENT SHOWED, THAT ALL COMPONENTS MANUFACTURED WITH THIS MATERIAL WOULD STILL MEET THE CLINICAL PERFORMANCE REQUIREMENTS. BASED ON THE MATERIAL STUDY (B)(4) IT WAS CONCLUDED, THAT THE FATIGUE STRENGTH OF THE MATERIAL MEETS THE INTERNAL REQUIREMENTS. MOREOVER, ZRM_WI_0707_07 CONCLUDED THAT A CLEAR INFLUENCE, THAT A (BAD) RATING ACCORDING TO ETTC-2 GUIDELINE (IN THE AREA OF RATINGS BETWEEN A1 TO A9) WOULD AFFECT NEGATIVELY THE FATIGUE BEHAVIOR COULD NOT BE PROVEN ACCORDING TO THE COMPLETED INVESTIGATION. THEREFORE THE RAW MATERIAL WAS RELEASED. CONCLUSION: ACCORDING TO THE RECEIVED INFORMATION THE PATIENT HAD A PRIMARY RIGHT HIP REPLACEMENT IN (B)(6) 2006. THIS PROSTHESIS WAS REVISED IN (B)(6) 2008 DUE TO AN INFECTION. A ONE-STAGE REVISION WAS PERFORMED AND A REVITAN STEM WAS IMPLANTED WITH A ZIMMER PRESS-FIT CUP AND A METASUL PAIRING. ACCORDING TO THE MEDICAL LETTER OF (B)(6) 2014 THE PATIENT HAD A HIGH LEVEL OF COBALT AND CHROMIUM IN BLOOD. THE SURGEON ATTRIBUTED THESE TO A WEAR PROBLEM AT THE METAL-ON-METAL INTERFACE THAT WOULD EXPLAIN THE EFFUSION AND PAIN IN THE RIGHT HIP. TO AVOID ANY DAMAGE TO THE HIP AND ESPECIALLY THE RISK OF PROGRESSIVE LOOSENING OF THE PROSTHETIC PARTS A REVISION WAS INDICATED. IT WAS SUGGESTED TO NOT ONLY REVISE THE ACETABULAR CUP BUT ALSO THE PROXIMAL PART OF THE REVITAN STEM TO RESTORE A DIFFERENCE IN LEG LENGTH, AS THE PATIENT¿S RIGHT LEG WAS SHORTER. THE SURGERY WAS PERFORMED IN (B)(6) 2014 AND THE PROXIMAL PART OF THE REVITAN STEM WAS REVISED TOGETHER WITH THE PRESS-FIT CUP AND THE METASUL PAIRING. A LONGER REVITAN PROXIMAL PART (65 MM COMPARED WITH THE PREVIOUS 55 MM) WAS IMPLANTED TOGETHER WITH A DURASUL HEAD (ZIMMER BIOMET PRODUCTS) AND A SATURNE DUAL MOBILITY CUP AND INSERT (AMPLITUDE PRODUCTS). AS COMBINATION OF PRODUCTS FROM DIFFERENT MANUFACTURERS WAS USED THIS HAS TO BE CONSIDERED OFF-LABEL USE. IN (B)(6) 2018 THE PATIENT UNDERWENT ANOTHER REVISION DUE TO A FRACTURE OF THE PROXIMAL PART OF THE REVITAN STEM. ACCORDING TO THE REVISION REPORT, A NEW REVITAN PROXIMAL PART WITH A SIZE OF 85 MM WAS IMPLANTED AS THE PATIENT STILL HAD A LEG LENGTH DIFFERENCE OF 2 CM. A COCR HEAD AND A SATURNE INSERT WERE IMPLANTED AS WELL. AN ANSM REPORT OF (B)(6) 2020 INFORMS THAT THE REVITAN STEM (DISTAL PART IMPLANTED IN (B)(6) 2008 AND PROXIMAL PART CHANGED IN (B)(6) 2018) WAS REVISED IN (B)(6) 2020 DUE TO A BREAKAGE OF THE DISTAL PART. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE RETRIEVALS AT HAND SHOW THAT THE SIZE OF THE PROXIMAL PART IS 75 MM AND NOT 85 MM AS DESCRIBED IN THE REVISION REPORT OF (B)(6) 2018. THE CONNECTION PIN IS DISCONNECTED FROM THE BODY OF THE DISTAL STEM PART. THE LATTER SHOWS A CIRCUMFERENTIAL FRACTURE APPROXIMATELY 20 MM BELOW ITS FACE SURFACE. BONE ATTACHMENTS CAN ONLY BE SEEN ON THE DISTAL PART. THE PROXIMAL PART EXHIBITS SEVERAL POLISHED AREAS AS A RESULT OF MOVEMENT AGAINST THE BONE AS WELL AS A STRIPE CONSISTING OF POLISHED HORIZONTAL LINES ON THE MEDIAL SIDE OF THE NECK. THE ORIGIN OF THE STIPE STAYS UNKNOWN. THERE IS ONLY ONE X-RAY AT HAND SHOWING A SITUATION THAT WOULD MATCH THE SITUATION DESCRIBED IN THE INDICATION SECTION OF THE REVISION REPORT DATED (B)(6) 2018. THEREFORE IT IS ASSUMED THAT THE X-RAY WAS TAKEN BEFORE THE REVISION IN (B)(6) 2018. AT THAT POINT IN TIME THERE WAS A RADIOLUCENT GAP BETWEEN THE CORTICAL BONE AND THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART WHICH EXTENDED SLIGHTLY TO THE PROXIMAL REGION OF THE DISTAL STEM PART. THE REVISION REPORT ONLY DOCUMENTS THAT THE BONE IS CLEANED FROM METAL DEBRIS AND THAT A NEW PROXIMAL PART IS IMPLANTED. AS A COMPLETE X-RAY FOLLOW-UP AS WELL AS A SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2020 IS NOT AT HAND, THE BONE SITUATION AROUND THE REVITAN STEM AND ITS DEVELOPMENT OVER TIME IN VIVO STAYS UNKNOWN. CONSIDERING THE ABOVE DESCRIBED SITUATION IT CAN ONLY BE ASSUMED THAT THE PROXIMAL BONE SUPPORT OF THE REVITAN STEM WAS SUBOPTIMAL OVER THE TIME IN VIVO. THE FINNED REGION OF THE DISTAL STEM PART WAS WELL FIXED. THIS SITUATION COULD HAVE LED TO AN OVERLOAD OF THE STEM RESULTING IN A LOOSENING OF THE CONNECTION PIN AND CHANGE OF ITS POSITION, SO IT CAME TO CONTACT BETWEEN THE FACE SURFACES OF THE PROXIMAL AND THE DISTAL PART RESULTING IN WEAR ON BOTH SURFACES. ADDITIONALLY, THE LOAD WAS NOT ANYMORE COMPLETELY BORNE BY THE CONNECTION PIN. THE LOOSENING OF THE PIN RESULTED IN WEAR OF THE STEM BODY¿S BORE HOLE. PROBABLY DUE TO THAT, THE PIN COULD TIP SO THAT ITS DISTAL END COULD PROP ON THE INSIDE OF THE DISTAL PART, FORM A NEW LEDGE AND DIMINISH THE WALL THICKNESS IN THIS AREA AS WELL AS PROXIMALLY ON THE OPPOSITE SIDE. THE CIRCUMFERENTIAL FRACTURE IS PROBABLY A CONCOMITANT OF THE CHANGED LOAD SITUATION. THE CONNECTION PIN SHOWS A MIXTURE OF POLISHING, SMEARING, FRETTING, CORROSION AND SOME CRACKS. THE FIRST TWO PHENOMENA ARE MOST PROBABLY CONCOMITANTS. HOWEVER, IT REMAINS UNCLEAR WHETHER THE LATTER THREE COULD HAVE HAD AN INFLUENCE ON THE FAILURE MODE OR ARE ONLY CONCOMITANTS AS WELL. ACCORDING TO THE REVISION REPORT OF (B)(6) 2018, THE DEFINITE REVITAN PROXIMAL PART WAS PLACED AND IMPACTED BEFORE BEING LOCKED WITH THE NUT AND THE TORQUE WRENCH. ACCORDING TO THE SURGICAL TECHNIQUE AVAILABLE TO THE OPERATING SURGEON AT THE TIME OF REVISION, WHEN ASSEMBLING THE PROXIMAL PART ON THE DISTAL PART, HAMMERING IS STRICTLY FORBIDDEN. IT IS NECESSARY TO USE THE ASSEMBLY TECHNIQUE DESCRIBED IN THE APPENDIX 1 OF THE SURGICAL TECHNIQUE. IN SHORT, THE PROXIMAL PART SHOULD BE POSITIONED ONTO THE TAPER OF THE DISTAL PART BY HAND, THE DESIRED ANTETORSION OF THE PROXIMAL PART SHOULD BE SET AND THEN THE TWO PARTS SHOULD BE PUSHED TOGETHER BY HAND TO GIVE THEM STABILITY. TO TIGHTEN THE ASSEMBLY OF THE TWO PARTS THE TORQUE WRENCH SHOULD BE USED. FINALLY THE SAFETY NUT SHOULD BE SCREWED ONTO THE THREADED PART OF THE TAPER WITH THE HELP OF THE SETTING INSTRUMENT AND TIGHTENED WITH THE TORQUE WRENCH. IF AND TO WHICH EXTENT THE ABOVE DESCRIBED IMPACTION DURING THE REVISION IN 2018 COULD HAVE HAD AN INFLUENCE ON THE LOOSENING OF THE CONNECTION PIN FROM THE DISTAL PART OF THE REVITAN STEM STAYS UNKNOWN. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN CAUSED BY IMPLANT FRACTURE AND METALLOSIS. THIS IS THE PATIENT'S THIRD REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981579 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140 N/A KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2443052

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R