REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 16/140
Report
- Report Number
- 0009613350-2019-00039
- Event Type
- Injury
- Date Received
- February 4, 2019
- Date of Event
- January 5, 2019
- Report Date
- November 26, 2019
- Manufacturer
- ZIMMER 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
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED. D11, CONCOMITANT MEDICAL DEVICES: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 85, TAPER 12/14, REF: (B)(4), LOT: 2532537. BIOLOX OPTION HEAD/ADPT 12/14 32X0, REF: 00-8777-032-02, LOT: 2538186. DURAL ALPHA INSERT NEUTR HH/32 REF: 01.00013.408, LOT: 2547857. IMPLANTATION SURGICAL REPORT WAS RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
INVESTIGATION RESULTS WERE MADE AVAILABLE DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: BREAKAGE, CORROSION, WEAR, LOOSENING NO LOT TRIGGER: ONLY 1 SIMILAR INVESTIGATED EVENT FOR THE LOT NUMBER 2568411 HAS BEEN FOUND. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE FEMALE PATIENT (BMI=27) UNDERWENT REVISION SURGERY ON (B)(6) 2019 DUE TO FRACTURE OF THE REVITAN STEM AFTER 8 YEARS AND 2 MONTHS IN-VIVO TIME. REVIEW OF RECEIVED DATA: X-RAYS: - (B)(6) 2009 PELVIS OVERVIEW AND SECOND VIEW ON THE RIGHT SIDE A THP WITH METASUL BEARING IS IMPLANTED. THE CUP¿S INCLINATION ANGLE WAS MEASURED AND AMOUNTS TO APPROXIMATELY 50°. COMPONENTS SEEM TO BE CORRECTLY IMPLANTED AND THERE ARE NO SIGNS OF LOOSENING. - (B)(6) 2010 PELVIS OVERVIEW, AP VIEW RIGHT HIP, 2X SECOND VIEW RIGHT HIP A PERIPROSTHETIC FEMORAL FRACTURE IS VISIBLE ON ALL X-RAYS. MULTIPLE BONE FRAGMENTS CAN BE SEEN. - 3X 23 (B)(6) 2010 PELVIS OVERVIEW, AP VIEW RIGHT FEMUR, SECOND VIEW RIGHT HIP COMPARED TO THE PREVIOUS X-RAYS THE SHELL IS STILL IN SITU BUT THE STEM AND THE BEARING COMPONENTS ARE REPLACED. THERE ARE TWO CERCLAGES AROUND THE FRACTURED TROCHANTER FRAGMENT. THE TROCHANTER MINOR FRAGMENT IS NOT COMPLETELY REDUCED. ON THE LATERAL SIDE THE BONE FRAGMENT IS WELL ATTACHED TO THE IMPLANT AND FIXED BY THE MOST PROXIMAL CERCLAGE OF THE THREE DISTAL ONES. THERE IS A GAP DERIVING FROM OSTEOTOMY BETWEEN THE MOST PROXIMAL AND THE MIDDLE CERCLAGE. THE MEDIAL FRAGMENT IS NOT COMPLETELY REDUCED (THE FRACTURE ENDS DO NOT MATCH TO EACH OTHER, NEITHER PROXIMALLY NOR DISTALLY). THE MOST DISTAL CERCLAGE IS PUT AROUND THE INTACT BONE BUT DOES NOT FIX THE DISTAL END OF THE MEDIAL BONE FRAGMENT. IN THE SECOND VIEW THE DISTAL BONE FRAGMENTS (LATERAL AND MEDIAL) APPEAR TO BE COMPLETELY REDUCED AND FIXED. IN THE PROXIMAL REGION AROUND THE CONNECTION BETWEEN THE STEM PARTS THERE IS ANTEROLATERAL AND POSTEROMEDIAL INCOMPLETE CONTACT BETWEEN THE IMPLANT AND THE BONE FRAGMENTS OBSERVABLE. - 2X (B)(6) 2011 PELVIS OVERVIEW, SECOND VIEW RIGHT HIP COMPARED TO THE PREVIOUS PELVIS OVERVIEW THE X-RAY SHOWS A DIFFERENT POSITION. THERE ARE NO FURTHER OBVIOUS CHANGES; THE BONE FRAGMENTS SHOW AN UNCHANGED POSITION. THE SECOND VIEW CANNOT BE COMPARED TO THE PREVIOUS ONE DUE TO THE DIFFERENT TYPE OF VIEW. THERE IS A GAP (POSTEROMEDIAL AND ANTEROLATERAL) BETWEEN THE PROXIMAL BONE FRAGMENT AND THE DISTAL BONE FRAGMENTS AS WELL AS BETWEEN THE BONE AND THE IMPLANT. -3X (B)(6) 2011 PELVIS OVERVIEW, SECOND VIEW RIGHT HIP THE TWO PROXIMAL CERCLAGES ARE BROKEN AND THE PROXIMAL BONE FRAGMENT APPEARS DISLOCATED TO CRANIALLY. THE DISTANCE BETWEEN THE TROCHANTER MINOR AND THE STEM IS SMALLER SO THAT THERE IS ALMOST COMPLETE CONTACT TO THE ADJACENT MEDIAL FRAGMENT. ON THE LATERAL SIDE BONY SUPPORT IS MISSING BETWEEN THE PROXIMAL TROCHANTER FRAGMENT AND THE DISTAL FRAGMENT. THERE IS SOME SLIGHT BONE FORMATION ON THE PROXIMAL BONE PART OF THE OSTEOTOMY GAP. THERE ARE NO OBVIOUS CHANGES VISIBLE ON THE SECOND VIEW. - 2X (B)(6) 2011 PELVIS OVERVIEW, SECOND VIEW RIGHT HIP COMPARED TO THE PREVIOUS PELVIS OVERVIEW THE TROCHANTER MAJOR FRAGMENT SEEMS TO BE FURTHER DISLOCATED TO CRANIAL. ON THE LATERAL SIDE THE PROXIMAL PORTION OF THE PROXIMAL STEM PART IS NOT COVERED BY BONE AND THE OSTEOTOMY GAP SEEMS TO BE UNCHANGED. SLIGHT CALLUS FORMATION CAN BE OBSERVED AT THE DISTAL FRACTURE FRAGMENT ON THE MEDIAL SIDE. THERE IS A PART OF CERCLAGE WIRE POSTERIORLY CLOSE TO THE STEM. IN THE DISTAL AREA THERE IS A PERIOSTAL CALLUS FORMATION POSTEROMEDIAL. THERE IS NO BONY BRIDGE BETWEEN THE PROXIMAL AND THE DISTAL FRAGMENT POSTEROMEDIAL. OTHERWISE THERE ARE NO REPORTABLE CHANGES COMPARED TO THE PREVIOUS SECOND VIEW X-RAY. - 3X (B)(6) 2012 2X PELVIS OVERVIEW, SECOND VIEW RIGHT HIP COMPARED TO THE PREVIOUS PELVIS OVERVIEW A PIECE OF CERCLAGE WIRE IS LOCATED PROXIMAL TO THE JOINT CLOSE TO THE PELVIC BONE AND ANOTHER PIECE CLOSE TO THE DISTAL RIM OF THE CUP. IT SEEMS THAT THERE IS CALLUS FORMATION IN THE AREA BETWEEN THE TROCHANTER MINOR AND THE ADJACENT DISTAL BONE FRAGMENT ON THE MEDIAL SIDE. ON THE LATERAL SIDE THE SITUATION IS UNCHANGED PROXIMALLY AND THE OSTEOTOMY GAP APPEARS TO BE SMALLER. THE ALREADY MENTIONED DISTAL MEDIAL CALLUS FORMATION PROGRESSED. THERE ARE NO OBVIOUS CHANGES VISIBLE ON THE SECOND VIEW. - 3X (B)(6) 2014 PELVIS OVERVIEW, AP VIEW RIGHT HIP, SECOND VIEW RIGHT HIP COMPARED TO THE PREVIOUS X-RAYS THE SITUATION SEEMS TO BE UNCHANGED. ON THE AP VIEWS THERE SEEMS TO BE NO DIRECT CONTACT BETWEEN THE STEM AND THE BONE IN THE AREA AROUND THE PROXIMAL STEM PART AS WELL AS ON THE MEDIAL SIDE IN THE DISTAL AREA JUST ABOVE THE MOST DISTAL CERCLAGE. - 2X (B)(6) 2019 PELVIS OVERVIEW, SECOND VIEW RIGHT HIP THE PELVIS OVERVIEW EXHIBITS A FRACTURE OF THE DISTAL STEM BODY BELOW THE DISTAL END OF THE CONNECTION PIN. THE LATTER IS DISPLACED TO LATERAL WHILE RESTING PARTIALLY ON THE LATERAL SIDE OF THE DISTAL FRACTURE PART. IT IS, TOGETHER WITH THE PROXIMAL STEM PART, TIPPED TO MEDIAL. A PIECE OF CERCLAGE WIRE IS LOCATED POSTEROLATERAL IN THE MEDULLARY CANAL. ON THE SECOND VIEW THE FRACTURE PART IS DISPLACED TO POSTERIOR. - 2X (B)(6) 2019 PELVIS OVERVIEW, SECOND VIEW RIGHT HIP THE X-RAYS SHOW THE SITUATION AFTER THE REVISION OF THE FRACTURED STEM. BESIDES THE CLINICAL INFORMATION ALREADY MENTIONED IN THIS REPORT, THE FOLLOWING ADDITIONAL INFORMATION OF THE SURGEON¿S LETTER CAN BE SUMMARIZED. IN 1999 PRIMARY IMPLANTATION WAS PERFORMED IN KANTONSSPITAL WINTERTHUR WHERE A CLS STEM, A FITEK CUP WITH METASUL INSERT AND METASUL HEAD WERE IMPLANTED ON THE RIGHT HIP SIDE. DUE TO A PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR A REVISION SURGERY HAD TO BE CONDUCTED ON (B)(6) 2010. STEM AND INSERT WERE REPLACED BY THE COMPONENTS MENTIONED IN THIS REPORT. IN THE FURTHER COURSE THE PATIENT WAS FREE OF COMPLAINTS AND WITHOUT INSUFFICIENCY OF THE ABDUCTORS DESPITE DISLOCATION OF THE TROCHANTERS. THREE TO FOUR MONTHS AGO THE PATIENT STARTED LIMPING. ON (B)(6) 2018 PAIN OCCURRED WHILE THE PATIENT WAS PLAYING THE ORGAN DURING A CONCERT. DUE TO THE RAPIDLY PROGRESSIVE AND FINALLY IMMOBILIZING PAIN THE PATIENT WAS ADMITTED IN EMERGENCY HOSPITAL CARE. A FATIGUE FRACTURE OF THE STEM WITH SECONDARY FRACTURE OF THE PROXIMAL FEMUR WAS DIAGNOSED. ON (B)(6) 2019 REVISION SURGERY TOOK PLACE. THERE WAS A PRONOUNCED METALOSIS WHICH WAS, HOWEVER, LIMITED TO THE TROCHANTERIC REGION AND THE JOINT. THERE ARE TRACES DERIVING FROM THE CHISEL ON THE PROXIMAL PART BECAUSE IT WAS PARTIALLY BONY INTEGRATED. THE FIXED DISTAL PART NEEDED TO BE LOOSENED BY LONGITUDINAL DRILLINGS AND TO BE REMOVED BY A LATERAL MILLED GROOVE. SINCE THE PRIMARY IMPLANTATION THE CUP HAD AN INCLINATION OF 53° AND AN EXCESSIVE ANTEVERSION, DESPITE THIS IT WAS LEFT IN SITU. HOWEVER, THE INSERT WAS CHANGED. IT WAS REMOVED USING A CHISEL. THERE IS A CORRESPONDING DAMAGE PRESENT ON THE OUTER SIDE OF THE POLYETHYLENE AT 12 O¿CLOCK. SURGICAL REPORT OF IMPLANTATION, (B)(6). 2010 DIAGNOSIS: PERIPROSTHETIC FEMUR FRACTURE RIGHT, STATE AFTER PRIMARY TOTAL IMPLANTATION RIGHT 11 YEARS AGO INDICATION: YESTERDAY THE PATIENT FELL DOWN THE STAIRS RESULTING IN THE ABOVE MENTIONED INJURY TECHNICAL PROCEDURE: A SUBVASTUS APPROACH IS USED AND THE FRACTURE EXPOSED. ACCORDING TO PLANNING AN OSTEOTOMY IS PERFORMED ON THE LATERAL CORTICAL BONE AND ADDITIONALLY AT THE PROXIMAL FRAGMENT IN THE TROCHANTER AND FOLDED TO MEDIAL. THE STEM IS REMOVED AND THE ACETABULUM SHOWN. A SUBTOTAL CAPSULOTOMY IS PERFORMED. THE METASUL LINER IS REMOVED AND A DURASUL INLAY IMPLANTED. THE FRACTURE IS REVEALED AND A PROTECTIVE CERCLAGE IS PUT. THE MEDULLARY CANAL IS PREPARED WITH THE SPECIAL RASP FROM 14 TO 16. THE TRIAL REPOSITION WITH A REVITAN STEM 85/140/16 SHOWS SUFFICIENT TENSION AND GOOD JOINT PLAY. A REVITAN STEM 85/149/16 IS DEFINITELY IMPLANTED AND A DEFINITE HEAD 32/M IS MOUNTED. THE MULTIFRAGMENT FRACTURE IS FIXED FROM DISTALLY TO PROXIMALLY WITH CERCLAGES. THE X-RAY CHECK SHOWS A VERY GOOD REPOSITIONING. ON THE MEDIAL SIDE THE DISTAL FRAGMENT IS DISLOCATED TO CAUDAL, IT CANNOT BE BETTER REPOSITIONED USING THE SPECIAL BONE FORCEPS. BECAUSE THE BONE IS VERY POROUS PROXIMALLY WE DO NOT WANT TO OPEN THE CERCLAGES AGAIN AND LEAVE THE SITUATION AS IS. THE FURTHER REPORT DESCRIBES THE CLOSURE. SURGICAL REPORT OF REVISION, (B)(6) 2019 DIAGNOSIS: FRACTURE OF THE STEM AND PSEUDARTHROSIS OF THE TROCHANTER AFTER TOTAL HIP PROSTHESIS (THP) REVISION WITH CHANGE OF STEM AND INSERT ON (B)(6) 2010 AFTER PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR OF TYPE UCS B2 AFTER IMPLANTATION OF AN UNCEMENTED THP 1999 INDICATION: DESPITE THE DEVELOPMENT OF A PSEUDARTHOSIS OF THE TROCHANTER MAJOR THE FOLLOW-UP AFTER THE REVISION OF THE PROSTHESIS WAS VERY GOOD. SEVERAL MONTHS AGO THE PATIENT STARTED TO LIMP AGAIN. PAIN OCCURRED DURING A CONCERT ON (B)(6) 2018 WHILE THE PATIENT WAS PLAYING THE ORGAN. A FATIGUE FRACTURE OF THE MODULAR REVISION STEM IS VISIBLE. THE BORE IN THE STEM HAD BEEN ENLARGED BY THE CONNECTION PIN AND IT CAME TO A FATIGUE FRACTURE ON THAT HEIGHT. TECHNICAL PROCEDURE: A KOCHER-LANGENBECK APPROACH IS USED. THE TROCHANTERIC REGION IS COVERED BY A FIBER CONVERTED BURSITIS TROCHANTERICA OF ABOUT 15 MM IN THICKNESS WHICH IS MOSTLY EXCISED. THERE ARE DIFFERENT AREAS WITH METALOSIS IN THE TROCHANTERIC REGION. THE THREE CERCLAGES ARE EXPOSED. THE FIRST CAN BE REMOVED WITHOUT PROBLEMS. THE OTHER TWO ARE STILL FIXED. THE SECOND CERCLAGE IS USED AS A REFERENCE FOR THE OSTEOTOMY WHICH IS PERFORMED BY OSCILLATING SAWING. THE LATERAL CORTICAL BONE SHOWED A PSEUDARTHROSIS OF THE TROCHANTER MAJOR AND PROXIMAL TO THE FIRST CERCLAGE THE BONE WAS FRACTURED AS WELL AND PROTRUDED BY METALOTIC TISSUE. THE TROCHANTERIC FRAGMENTS ARE MOBILIZED ANTERIORLY AND THE METALOSIS IS REMOVED. THE FRACTURED STEM IS IDENTIFIED AND PARTIAL CAPSULOTOMY IS PERFORMED SO THAT THE PROXIMAL FRAGMENT OF THE STEM CAN BE REMOVED. THE DISTAL PART OF THE STEM IS FIXED. THE CAPSULOTOMY IS COMPLETED AND THE VERY PRONOUNCED METALOSIS IS DEBRIDED. SEVERAL FRAGMENTS OF THE WIRE CERCLAGE ARE REMOVED. THE CUP HAS AN OVERHANG OF MORE THAN 10 MM LATERAL AND POSTERIOR BUT IS FIRMLY INTEGRATED IN THE BONE. THE FRAGMENT OF THE TROCHANTER MINOR IS MOBILIZED BY CHISELS TO ALLOW SUFFICIENT REPOSITION. A NUT IS DRILLED IN THE LATERAL PROXIMAL STEM TO USE A PUSHER TO REMOVE THE STEM. FIRST, THE STEM IS LOOSENED BY DRILLING ALONG THE STEM. SUBSEQUENTLY, IT CAN BE REMOVED WITHOUT PROBLEMS. THE MEDULLARY CANAL IS REAMED IN STEPS FROM 7 TO 18 MM AND LAVAGE IS PERFORMED. THE ACETABULUM IS NEWLY EXPOSED. THE INSERT IS REMOVED WITH A CHISEL. THE POLYETHYLENE SHOWS A NORMAL YELLOWING OF THE ARTICULATION SURFACE EXCEPT AT 12 O¿CLOCK WHERE BEGINNING WEAR IS VISIBLE. THERE ARE NO PATHOLOGIC DEPOSITS AT THE INTERFACE. RINSING IS PERFORMED AND A NEW INSERT IS PLACED. PROTECTIVE CERCLAGES ARE PUT AND THE STEM BED IS REAMED USING REAMERS FROM 18 TO 22. A TRIAL STEM 22 X140 MM WITH PROXIMAL PART 75 MM IS PLACED AND REPOSITION IS PERFORMED WITH A M-HEAD. THERE IS NOT ENOUGH AXIAL TENSION BUT THE STEM IS STABILE IN EXTENSION AND EXTERNAL ROTATION OF 60° AS WELL AS IN FLEXION AND INTERNAL ROTATION OF MORE THAN 30°. SUBSEQUENTLY, AN IMPINGEMENT BY THE FRAGMENT OF THE TROCHANTER MINOR IS LIMITED. THE TRIAL COMPONENTS ARE REMOVED AND LAVAGE IS CONDUCTED. A DISTAL PART 22X140 MM IS IMPACTED; IT STOPS AT THE DESIRED DEPTH. A PROXIMAL PART 75 MM WITH 10° ANTEVERSION IS MOUNTED. TRIAL REPOSITION WITH A M-HEAD CONFIRMS THE BETTER AXIAL TENSION WITH THE STEM POSITION 3 MM PROXIMAL TO THAT OF THE TRIAL. THE TISSUE TENSION IS ADDITIONALLY IMPROVED BY THE REPOSITION OF THE TROCHANTERS. A HEAD 32 M IS MOUNTED, THE JOINT REDUCED AND THE FRAGMENTS ARE FIXED FROM DISTALLY TO PROXIMALLY. X-RAY CHECK IS PERFORMED. THE BONE IS MEDIALLY ATTACHED TO THE STEM EVEN IF THE TROCHANTER MINOR COULD NOT BE COMPLETELY REPOSITIONED. THE LATTER IS IN MEDIAL INSTEAD OF POSTEROMEDIAL POSITION. THE TROCHANTER MAJOR IS ADDITIONALLY FIXED WITH FIBERWIRE THROUGH THE HOLES OF THE PROXIMAL PART. THE REST OF THE REPORT DESCRIBES THE FURTHER CLOSURE PROCEDURE. DEVICES ANALYSIS - VISUAL EXAMINATION: THE DURASUL ALPHA INSERT IS PARTIALLY, SLIGHTLY YELLOWISH DISCOLORED ON THE ARTICULATION AS WELL AS THE ANCHORING SIDE. ON THE LATTER FEW SCRATCHES, NICKS AND THE ELEMENTS OF THE CONTOUR OF THE SHELL ARE VISIBLE. THERE ARE SLIGHT BACKSIDE CHANGES MAINLY IN THE AREA OF THE DISCOLORATION WHICH SEEMS TO BE LOCATED IN THE LOADED AREA. ON THE ARTICULATION SIDE THE RIM IS DAMAGED BY SCRATCHES, CUT-INS (E.G. CHISEL DAMAGE AS DESCRIBED BY THE SURGEON IN HIS LETTER) AND OTHER MARKS PROBABLY DERIVING FROM INSTRUMENTS. NUMEROUS FINE AND FEW COARSE SCRATCHES CAN BE SEEN ON THE ARTICULATION SURFACE. CLOSER INSPECTION WITH A LOW POWER MICROSCOPE (LEICA MZ16 A) REVEALED THAT THERE IS ONLY A SMALL AREA WHERE MACHINING MARKS NERVED BY SCRATCHES CAN BE DETECTED. IN THIS AREA THE POLYETHYLENE IS NOT DISCOLORED. IN THE AS-DELIVERED STATE THE BIOLOX DELTA HEAD WAS STILL MOUNTED ON THE REVITAN STEM TAPER. THERE IS METALLIC SMEARING ON THE BOTTOM FACE AND BEVEL OF THE HEAD. THE REVITAN STEM WAS RECEIVED DISCONNECTED AT THE CONNECTION BETWEEN THE CONNECTION PIN AND THE DISTAL STEM BODY. THE PROXIMAL PART OF THE STEM AND THE CONNECTION PIN WERE STILL ASSEMBLED. THE DISTAL PART WAS FRACTURED IN TWO PIECES. ON THE ANCHORING SURFACE OF THE PROXIMAL PART SHINY POLISHED AREAS IN THE NECK AND PROXIMAL HALF OF THE PART ARE VISIBLE. THOSE ARE LESS PRONOUNCED ON THE ANTERIOR SIDE. IN THE DISTAL HALF OF THE PROXIMAL PART HORIZONTAL POLISHED STRIPES ARE RUNNING FROM THE LATERAL TO THE MEDIAL SIDE VIA POSTERIOR. IN BOTH HALVES THERE ARE SMALL AREAS THAT ARE WORN IN SUCH A WAY THAT A SLIGHT DEEPENING CAN BE PALPATED WITH THE FINGER NAIL. FURTHER, SOME DAMAGES LIKELY FROM THE REVISION SURGERY SUCH AS DIFFUSE SCRATCHES AND DENTS IN LONGITUDINAL DIRECTION CAN BE OBSERVED. BONE ATTACHMENTS ARE NOT RECOGNIZABLE ON THE ENTIRE ANCHORING SURFACE. EXCEPT FOR THE LATERAL PORTION THE DISTAL FACE SURFACE IS POLISHED. ITS MEDIAL SHOULDER IS WORN SO THAT THE SURFACE HAS A 45° ANGLE. THERE IS ALSO A POLISHED AREA ON THE BLASTED SURFACE OF THE CONNECTION PIN CLOSE TO THE MEDIAL SHOULDER. THE CONNECTION PIN IS NOT ANYMORE IN ITS ORIGINAL SHAPE AND SHOWS A MIXTURE OF POLISHING, SMEARING AND CORROSION . THE LATTER IS LOCATED IN THE LATERAL HALF OF THE PIN AND WAS INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE (SEM) TYPE JEOL JSM-6610. BEFORE THE BIOLOX HEAD WAS REMOVED TO PERMIT PLACEMENT OF THE PROXIMAL PART IN THE SAMPLE CHAMBER OF THE SEM. THE ANALYZED REGION SHOWS CORROSION AND A PATTERN OF DIAGONAL STRIPES WHICH SEEM TO BE A TRANSFER FROM THE BORE OF THE DISTAL STEM BODY. THE DISTAL PART FRACTURED CIRCUMFERENTIALLY APPROXIMATELY 20 MM BELOW ITS FACE SURFACE. THE PROXIMAL FRACTURE PART IS WORN THROUGH SO THAT LESS THAN A 1 MM MATERIAL IS REMAINING PROXIMAL MEDIAL. THE FACE SURFACE IS WORN AS WELL IN THIS REGION AND ON THE TWO OPPOSING SHOULDERS. EXAMINING THE OTHER END OF THE FRACTURE PART, THE MATERIAL THICKNESS IS OBVIOUSLY DIMINISHED ON THE LATERAL SIDE. THE FRACTURE ORIGINATED IN THIS AREA FROM THE OUTSIDE TO THE INSIDE AND CONTINUES TO BOTH SIDES ALONG THE CIRCUMFERENCE. THE FRACTURE SURFACE IS PARTIALLY POLISHED. IT WAS INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE (SEM) TYPE JEOL JSM-6610. PARTIALLY, THE FRACTURE STRUCTURE IS LEVELED AND POLISHED. THE FRACTURE STRUCTURE INDICATES FATIGUE. SIGNS OF RESIDUAL FRACTURE COULD BE OBSERVED IN A VERY SMALL PORTION OF THE FRACTURE SURFACE LOCATED OPPOSITE THE FRACTURE ORIGIN. 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. HALF OF THE REMAINED POSTERIOR WALL IS WORN AS WELL. ON THE FRACTURE SURFACE THERE ARE MORE POLISHED ZONES THAN ON THE PROXIMAL ONE. ON THE ANCHORING SURFACE A BORE HOLE AND INSTRUMENT MARKS DERIVING FROM THE REMOVAL CAN BE SEEN. BONE ATTACHMENTS ARE OBSERVABLE IN THE DISTAL HALF OF THE PART. - MEASUREMENTS: THE WEAR MEASUREMENT WAS CARRIED OUT ON A 3D MEASURING MACHINE TYPE CMM5, SIP GENEVA. HOWEVER, THE WEAR MAP DOES NOT SHOW A CLEAR WEAR ZONE AND THEREFORE THE DETERMINATION OF THE WEAR VALUE IS NOT POSSIBLE, BUT THE DIAMETER CALCULATED OUT OF ALL MEASURING POINTS IS STILL WITHIN THE MANUFACTURING TOLERANCES. 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. - CORRECT IMPLANTATION OF THE REVITAN STRAIGHT STEM IS EXPLAINED IN SURGICAL TECHNIQUE. CONCLUSION SUMMARY: ON (B)(6) 2010 A REVITAN STEM WAS IMPLANTED FOLLOWING A MULTIFRAGMENT PERIPROSTHETIC FRACTURE. DURING REDUCTION ON THE MEDIAL SIDE THE DISTAL FRAGMENT IS DISLOCATED TO CAUDAL. BECAUSE THE BONE WAS VERY POROUS PROXIMALLY THE SITUATION WAS LEFT AS IS. ALREADY FOUR MONTHS LATER, THE PROXIMAL BONE FRAGMENT DISLOCATED CRANIALLY AND IT CAME TO A FRACTURE OF THE TWO PROXIMAL CERCLAGES. THE FURTHER X-RAY FOLLOW-UP SHOWS THAT PARTIAL BONE HEALING STARTED OCCURRING AT THE DISTAL FRAGMENT ON THE MEDIAL SIDE APPROXIMATELY ONE YEAR AFTER THE SURGERY. HOWEVER, THROUGHOUT THE ENTIRE TIME IN VIVO A GAP WITHOUT BONE REMAINED BETWEEN THE PROXIMAL BONE FRAGMENT INCLUDING THE TROCHANTERS AND THE REST OF THE BONE. IT SEEMS AS WELL THAT THE GAP ON THE LATERAL SIDE DERIVING FROM THE OSTEOTOMY DID NEVER CLOSE COMPLETELY. ON (B)(6) 2019 THE REVITAN STEM HAD TO BE REVISED DUE TO FRACTURE. THE REPORT OF THE REVISION SURGERY DESCRIBES THAT THERE WERE SEVERAL AREAS OF METALOSIS IN THE REGION OF THE TROCHANTER AND THERE WAS A PSEUDARTHROSIS OF THE TROCHANTER MAJOR. THE RETRIEVALS AT HAND SHOW A FRACTURE OF THE STEM BODY OF THE DISTAL PART APPROXIMATELY 20 MM BELOW ITS PROXIMAL END. BONE ATTACHMENTS CAN ONLY BE SEEN IN THE DISTAL HALF OF THE DISTAL PART. THE PROXIMAL PART EXHIBITS SEVERAL POLISHED AREAS AS A RESULT OF MOVEMENT AGAINST THE BONE AND / OR PARTS OF THE CERCLAGES INDICATING LOOSENING. BASED ON THE X-RAY EVALUATION AND THE APPEARANCE OF THE PARTS IT IS ASSUMED THAT THE PROXIMAL BONE SUPPORT WAS SUBOPTIMAL OVER THE ENTIRE TIME IN VIVO AND THE PROXIMAL PART WAS LOOSE WHILE AT LEAST THE DISTAL HALF 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. THE CIRCUMFERENTIAL FRACTURE IS PROBABLY A CONCOMITANT OF THE CHANGED LOAD SITUATION. THE CONNECTION PIN SHOWS A MIXTURE OF POLISHING, SMEARING AND CORROSION. THE FIRST TWO PHENOMENA ARE MOST PROBABLY CONCOMITANTS. HOWEVER, IT REMAINS UNCLEAR WHETHER THE CORROSION COULD HAVE HAD AN INFLUENCE ON THE FAILURE MODE OR IS ONLY A CONCOMITANT AS WELL. FURTHER, IT IS UNKNOWN IF OTHER FACTORS INCLUDING PATIENT FACTORS, E.G. BMI, ACTIVITY, COULD HAVE HAD AN INFLUENCE ON THE COURSE OF EVENTS. THE DURASUL ALPHA INSERT SHOWS AN INCONSPICUOUS APPEARANCE. A WEAR MEASUREMENT WAS PERFORMED. HOWEVER, THE WEAR MAP DOES NOT SHOW A CLEAR WEAR ZONE AND THEREFORE THE DETERMINATION OF THE WEAR VALUE IS NOT POSSIBLE, BUT THE DIAMETER CALCULATED OUT OF ALL MEASURING POINTS IS STILL WITHIN THE MANUFACTURING TOLERANCES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION THE COMPLAINT COULD BE CONFIRMED. HOWEVER, NO EXACT ROOT CAUSE COULD BE IDENTIFIED. 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).
NO EVENT UPDATE.
NO EVENT UPDATE.
CONCOMITANT MEDICAL DEVICES: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 85, TAPER 12/14, REF: 01.00402.085, LOT: UNKNOWN. BIOLOX OPTION HEAD/ADPT 12/14 32X0, REF: 00-8777-032-02, LOT: UNKNOWN. DURAL ALPHA INSERT NEUTR HH/32 REF: 01.00013.408, LOT: UNKNOWN. 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. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION BUT IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE PROVIDED. X-RAY PICTURES AND SURGICAL REPORT OF IMPLANTATION WERE RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. FURTHER INFORMATION HAS BEE REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE OF THE REVITAN DISTAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95296 | REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 16/140 | REVITAN DISTAL PART | KWA | ZIMMER GMBH | N/A | 2568411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |