SULOX, HEAD, M¸ 32/0, TAPER 12/14
Report
- Report Number
- 0009613350-2018-00748
- Event Type
- Injury
- Date Received
- August 3, 2018
- Date of Event
- June 21, 2018
- Report Date
- November 29, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWB
- PMA / PMN Number
- PNA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K923808. 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 THE HEAD. REVIEW OF EVENT DESCRIPTION: SINCE THE END OF (B)(6) 2018 THE PATIENT FELT A CRACKING WITH MOVEMENT NOISE IN THE LEFT HIP WITHOUT TRAUMA AS WELL AS PAIN AND INSTABILITY. THE HIP PROSTHESIS WAS THEN REVISED AFTER APPROXIMATELY 9 YEARS AND 10 MONTHS IN VIVO DUE TO A RADIOLOGICALLY OBSERVED FRACTURE OF THE CERAMIC FEMORAL HEAD. REVIEW OF RECEIVED DATA - REVIEW OF AVAILABLE INFORMATION: THE IMPLANT CERTIFICATE FOR THE PATIENT WITH THE AFFIXED PRODUCT STICKERS DID NOT INCLUDE ANY ADDITIONAL INFORMATION RELEVANT TO THE CASE THAT IS NOT ALREADY STATED IN THIS REPORT. THE INFORMATION FROM THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) IS ALSO SUMMARIZED IN THIS REPORT OR CORRESPONDS WITH THE INFORMATION IN ONE OF THE DOCUMENTS BELOW. BFARM INCIDENT REPORT: THE DESCRIPTION OF THE EVENT STATES THAT THE POST-SURGERY COURSE OF THE IMPLANTATION SURGERY WAS WITHOUT COMPLICATIONS. IN (B)(6) 2018 THE PATIENT EXPERIENCED A DISLOCATION OF THE LEFT HIP DUE TO A TRAUMA. A CLOSED REDUCTION WAS PERFORMED IN (B)(6). IN (B)(6) 2018 ANOTHER DISLOCATION OCCURRED WHICH WAS REDUCED IN (B)(6) AS WELL. SINCE ABOUT (B)(6) 2018 THE PATIENT FELT A CRACKING WITH MOVEMENT NOISE IN THE LEFT HIP WITHOUT TRAUMA AS WELL AS PAIN AND INSTABILITY. THE RADIOGRAPH SHOWED A FRACTURE OF THE CERAMIC FEMORAL HEAD. ON (B)(6) 2018 A COMPLETE REVISION OF THE HIP PROSTHESIS WAS PERFORMED IN KLINIK BAD WINDSHEIM. THE FRAGMENTS OF THE HEAD WERE REMOVED, CUP AND STEM EXCHANGED AND A CERAMIC-CERAMIC PAIRING WAS IMPLANTED. IMPLANTATION SURGERY REPORT, (B)(6) 2008: POSTERIOR APPROACH IS PERFORMED TO OPEN THE LEFT HIP JOINT. AN ARCH-SHAPED INCISION IS MADE ABOVE THE GREATER TROCHANTER. THE LEG LENGTH IS MEASURED AND SHOWS THAT THE LEG TO BE TREATED IS 1 CM LONGER COMPARED TO THE OPPOSITE SIDE (PELVIC OBLIQUITY). THE HIP JOINT IS DISLOCATED AND AN OSTEOTOMY OF THE FEMORAL NECK IS PERFORMED WITH THE OSCILLATING SAW APPROXIMATELY 1 CM PROXIMAL TO THE TROCHANTER MINOR. THE ACETABULUM IS MILLED UP TO A DIAMETER OF 52 MM. A CANCELLOUS BONE PLASTIC IS PERFORMED ON THE BOTTOM OF THE ACETABULUM USING CANCELLOUS BONE PREVIOUSLY OBTAINED DURING THE MILLING PROCESS. THEN AN ALLOFIT SHELL 52/32 IS IMPACTED WITH AN INCLINATION OF 40° TO THE HORIZONTAL AND AN ANTEVERSION OF 15°. A HOODED DURASUL INSERT IS INSERTED, WHOSE HOOD IS PLACED DORSOCRANIAL. THE FEMORAL CANAL IS OPENED WITH A CHISEL AND PREPARED WITH A RASP FOR A CLS SPOTORNO 135° STEM SIZE 9. A TRIAL HEAD IS PLACED ON THE RASP AND A TRIAL REDUCTION OF THE HIP JOINT IS PERFORMED. WITH A HEAD SIZE M, THE PRE-EXISTING LEG LENGTH CAN BE ACHIEVED. THE TRIAL COMPONENTS ARE REMOVED AND THE STEM IS IMPACTED. A SULOX 32 M 12/14 CERAMIC HEAD IS PLACED AND THE HIP JOINT IS REDUCED. THERE IS A GOOD JOINT LAXITY AT FREE MOBILITY. THE HIP JOINT IS CLOSED. REVISION SURGERY REPORT, (B)(6) 2018: ON THE REPORT THE PATIENT¿S WEIGHT AND HEIGHT ARE NOTED HANDWRITTEN. THE REPORT DESCRIBES THE REVISION OF THE LEFT HIP JOINT WITH DEBRIDEMENT OF THE METALLOSIS IN THE AREA OF A PSEUDOBURSA SUBFASCIAL. THE HIP PROSTHESIS WAS COMPLETELY REPLACED INCLUDING THE REMOVAL OF THE CLS STEM WITH A DESTROYED TAPER AND IMPLANTATION OF NEW COMPONENTS. THE HISTORY CORRESPONDS WITH THE BFARM INCIDENT REPORT. THE FIRST DISLOCATION OCCURRED DUE TO A FALL OF THE PATIENT. IN ADDITION, IT IS DESCRIBED THAT ABOUT 10 DAYS AGO ON A CAR DRIVE THE PATIENT FELT A SUDDEN CRASH IN THE LEFT HIP JOINT WITH CRUNCHING SOUNDS AND PAIN. THE X-RAY CHECK REVEALED A FRACTURED CERAMIC HEAD. THE PROCEDURE IS PERFORMED IN THE RIGHT SIDE POSITION BY EXCISION OF THE OLD SCAR. THE SUBCUTANEOUS TISSUE IS TRANSECTED UNDER CAREFUL HEMOSTASIS. SUBFASCIAL A PSEUDOBURSA IS DISCOVERED WHICH DRAINS SEROUS FLUID. A BIG PSEUDOBURSA IS SHOWN SUBFASCIAL, WHICH SHOWS A CLEAR METALLOSIS. THIS BURSA IS EXCISED AS FAR AS POSSIBLE. SAMPLES ARE TAKEN FOR HISTOLOGICAL AND BACTERIOLOGICAL EXAMINATION. THE LARGE HEAD FRAGMENTS ARE THEN RECOVERED. THERE ARE STILL SEVERAL SMALLER FRAGMENTS OF THE CERAMIC HEAD, WHICH ARE REMOVED AS FAR AS POSSIBLE. THE STEM TAPER HAS SIGNIFICANT DAMAGE BY THE CERAMIC PARTICLES, SO THAT THE DECISION IS MADE TO REMOVE THE STEM. THE CRANIAL SIDE OF THE INSERT IS CLEARLY DAMAGED BY THE PRESSURE OF THE STEM TAPER. ADDITIONAL SAMPLES ARE TAKEN FOR HISTOLOGY AND BACTERIOLOGY FROM THE FEMORAL NECK AND HIP JOINT. THE STEM IS FREED UNTIL IT CAN BE EASILY REMOVED. IT ONLY COMES TO A SMALL FISSURE VENTRAL IN THE METAPHYSEAL AREA, BUT IT DOES NOT EXTEND INTO THE STEM. OTHERWISE, THE PROXIMAL FEMUR IS COMPLETELY INTACT. A SAMPLE FOR HISTOLOGY AND BACTERIOLOGY IS TAKEN FROM THE FEMUR. THEN THE ATTENTION IS TURNED TO THE ACETABULAR COMPONENT, WHICH IS CUT OUT FIRST WITH A SHORT THEN WITH A LONG KNIFE. THE SHELL WITH THE INSERT CAN BE REMOVED WITHOUT MAJOR BONE LOSS. A SAMPLE IS COLLECTED AND RELEASED FOR HISTOLOGY AND BACTERIOLOGY FROM THE ACETABULAR BOTTOM. THE ACETABULUM IS GRADUALLY PREPARED. BEFORE REAMING, IT WAS ALREADY EVIDENT THAT THE ACETABULAR BOTTOM HAS A HOLE WHERE ONLY CONNECTIVE TISSUE IS VISIBLE AS A BORDER TO THE SMALL BASIN. THEREFORE THE REAMING IS PERFORMED TO CRANIAL AND NOT IN DEPTH. AFTER TRIAL PLACEMENT AN ALLOFIT S-IT SHELL Ø56 IS INTRODUCED WITH AN ANTEVERSION OF 20° AND AN INCLINATION OF 45°. A BIOLOX DELTA CERAMIC INSERT FOR A HEAD Ø36 IS USED. THE FEMUR IS PREPARED AND AN AIIOCLASSIC SLL STEM SIZE 3 WITH AN XL HEAD Ø36 IS IMPACTED. THE HIP IS REPOSITIONED, RINSED AND CLOSED. X-RAYS: A PELVIS OVERVIEW X-RAY WAS TAKEN ON (B)(6) 2008 BEFORE THE IMPLANTATION SURGERY. IT IS VISIBLE THAT THE NATURAL INCLINATION ANGLE IS RATHER STEEP AND THE DEPTH OF THE ACETABULUM RATHER LOW. THE FIRST X-RAY IS A POST-OPERATIVE AP VIEW OF THE LEFT HIP TAKEN ON (B)(6) 2008. THE X-RAY IS RATHER DARK AND THE OUTLINES OF THE BONES AND IMPLANTED COMPONENTS ARE BARELY VISIBLE. SOME STAPLES AND REDON DRAIN CAN BE SEEN ON THE LATERAL SIDE. ON THE PELVIS OVERVIEW TAKEN ON (B)(6) 2008 IT SEEMS THAT THE CUP¿S DOME SLIGHTLY PROTRUDES INTO THE SMALL BASIN. THE X-RAY WAS USED TO MEASURE THE INCLINATION ANGLE OF THE CUP WHICH IS APPROXIMATELY 55°. USING X-RAY TEMPLATES THE ANTE- OR RETROVERSION IS ESTIMATED WITH TO BE ABOUT 20°. THE ESTIMATED INCLINATION AND ANTE- OR RETROVERSION ANGLES DEVIATE FROM THE INFORMATION GIVEN IN THE IMPLANTATION SURGERY REPORT. ON THE PELVIS OVERVIEW DATED (B)(6) 2018 IT IS CLEARLY VISIBLE THAT THE CERAMIC HEAD IS FRACTURED. SEVERAL FRACTURE FRAGMENTS CAN BE OBSERVED IN THE REGION OF THE GREATER TROCHANTER. ON THE SAME DATE A CT WAS TAKEN AS WELL. ON THIS IMAGE THE FRACTURE FRAGMENTS ARE RECOGNIZABLE IN THE REGION OF THE CUP. WHEN COMPARING THE PELVIS OVERVIEWS TAKEN DURING TIME IN VIVO A CHANGE OF THE POSITION OF THE REMAINING COMPONENTS CANNOT BE OBSERVED. FURTHER, THERE ARE NO OBVIOUS CHANGES TO THE BONE NOTICEABLE. SOME INTRAOPERATIVE X-RAY IMAGES SHOW THE TRIAL COMPONENTS OF THE NEW IMPLANTS. X-RAYS TAKEN ON (B)(6) 2018 AFTER REVISION SURGERY WERE ALSO RECEIVED AND DO NOT REVEAL ANYTHING RELEVANT TO THE CURRENT CASE. DEVICES ANALYSIS: VISUAL EXAMINATION OF BROKEN HEAD - CONDUCTED BY METOXIT. THE ATTACHED EXAMINATION REPORT FROM METOXIT DOES CONFIRM THAT THE MATERIAL SPECIFICATIONS ARE MET. DUE TO MISSING 3.2% OF MISSING FRAGMENTS, NO FURTHER CONCLUSION COULD BE DRAWN. VISUAL EXAMINATION DONE AT ZIMMER BIOMET WINTERTHUR. THE CLS SPOTORNO STEM SHOWS BONE ONGROWTH ON THE ENTIRE ANCHORING SURFACE WHEREAS THE BONE ONGROWTH IS LESS ON THE MEDIAL AND LATERAL SIDE. THE NECK REGION IS HEAVILY SCRATCHED MAINLY ON THE ANTERIOR, MEDIAL AND POSTERIOR SIDE. THE LATERAL SIDE EXHIBITS SOME SCRATCHES, NICKS, SLIGHT POLISHING AND POLISHED GROOVES. ONE GROOVE IS LOCATED AT THE DISTAL END OF THE STEM TAPER WHILE TWO PARALLEL GROOVES CAN BE OBSERVED IN THE MIDDLE OF THE NECK REGION. THE TAPER ITSELF IS DAMAGED AND WORN IN SUCH A WAY THAT IT IS NO LONGER IN ITS ORIGINAL SHAPE AND SCRATCHES AS WELL AS INDENTS COVER THE TAPER. A CLEARLY WORN AREA CAN BE OBSERVED IN THE LATERAL REGION OF THE TAPER. THE TAPER ALSO EXHIBITS SOME BLUEISH DISCOLORATION TOWARDS ITS PROXIMAL END AND SOME WHITISH DEPOSIT DISTRIBUTED ON THE ENTIRE TAPER. ON THE FACE SURFACE OF THE TAPER SOME WHITE-YELLOWISH DEPOSIT CAN ALSO BE OBSERVED. CLOSER INSPECTION OF THE STEM TAPER WITH A LOW POWER MICROSCOPE (LEICA MZ16 A) USING POLARIZATION CONTRAST WAS PERFORMED. THE WHITISH DEPOSITS CAN MAINLY BE OBSERVED IN THE ROOTS OF THE TAPER STRUCTURE AND ALSO ON THE CRESTS. IN ISOLATED AREAS A DEPOSIT LAYER IS RECOGNIZABLE AND IT SEEMS THAT IN THOSE AREAS THE TAPER STRUCTURE DOES NOT EXIST ANYMORE. THE DEPOSIT HAS A GLASSY AND BRITTLE APPEARANCE SIMILAR TO BONE OR BONE CEMENT AND IS YELLOWISH DISCOLORED IN SOME AREAS. THE CERAMIC HEAD IS FRACTURED IN SEVERAL PIECES. FOUR LARGER FRAGMENTS AND SOME SMALLER ONES WERE RECEIVED. SOME OF THE PIECES SHOW SOME METALLIC SMEARING ON THE ARTICULATION SURFACE . ON A FEW FRACTURE PIECES SOME POSSIBLY ORGANIC DEPOSITS ARE ALSO OBSERVABLE. THE HEAD TAPER SHOWS NO EVENLY DISTRIBUTED MATERIAL TRANSFER FROM THE STEM TAPER WHICH IS COMMONLY OBSERVED. ON THREE OF THE FRACTURE FRAGMENTS SOME WHITISH ROUGHENED STRIPE CAN BE SEEN AT THE PROXIMAL END OF THE HEAD TAPER. CLOSER INSPECTION SHOWED A STRIPE WITH WHITISH DEPOSIT SIMILAR TO THE DEPOSITS FOUND ON THE STEM TAPER. UPON RECEIPT THE DURASUL® ALPHA HOODED INSERT AND THE ALLOFIT® ALLOCLASSIC® SHELL WERE ASSEMBLED AND THE INSERT WAS FIRMLY FIXED IN THE SHELL. A REMOVAL OF THE INSERT FROM THE SHELL WAS CARRIED OUT FOR FURTHER INVESTIGATION. THE DURASUL® ALPHA HOODED INSERT EXHIBITS SLIGHT DAMAGES AND INSTRUMENT INDENTATIONS FROM THE REVISION SURGERY ON AND AROUND THE RIM. APPROXIMATELY IN THE MIDDLE OF THE HOODED AREA A PART OF A SICKLE-SHAPED DEFORMED AND SLIGHTLY WORN ZONE CAN BE DISCOVERED. THE ARTICULATION SURFACE IS ROUGHENED, PARTIALLY YELLOWISH DISCOLORED AND SOME GREYISH DEBRIS IS EMBEDDED. CLOSER INVESTIGATION REVEALED SMALL CERAMIC PARTICLES THAT ARE COVERED BY A METAL TRANSFER DUE TO CONTACT WITH THE STEM TAPER. AN INDENTATION DERIVING FROM DIRECT CONTACT WITH THE STEM TAPER CAN ALSO BE SEEN. THE ANCHORING SIDE OF THE INSERT IS PARTIALLY YELLOWISH DISCOLORED AND MIRRORS THE CONTOUR OF THE ALLOFIT® ALLOCLASSIC® SHELL. THE IMPRINTS OF THE HOLES ARRANGED IN ONE HALF OF THE BACKSIDE CAN BE RECOGNIZED. ONE OF THE IMPRINTS IS LOCATED ON THE OUTSIDE OF THE WALL WHERE THE STEM'S INDENTATION IS LOCATED AND PROTRUDES SLIGHTLY. FURTHER A PAIR OF INDENTATIONS ORIGINATING FROM THE SHELL¿S ANTI ROTATIONAL SPIKES CAN BE SEEN. CLOSER INSPECTION OF THE ANCHORING SIDE WITH A BINOCULAR (WILD M38, HEERBRUGG SWITZERLAND) REVEALED BACKSIDE CHANGES AROUND THE IMPRINTS OF THE HOLES AND CLOSE TO THE POLE. THE REMAINING SURFACE EXHIBITS ORIGINAL MACHINING LINES. THE POLE PIN OF THE INSERT EXHIBITS SOME DAMAGE ON ONE SIDE. THERE ARE BONE ATTACHMENTS VISIBLE ON THE ANCHORING SIDE OF THE ALLOFIT® ALLOCLASSIC® SHELL. THE BONE ATTACHMENTS ARE MAINLY AROUND THE EQUATOR AND IN THE AREA OF THE POLE. IN SOME AREAS THE TOP OF THE ANCHORING FINS ARE SLIGHTLY DAMAGED WHICH COULD PROBABLY DERIVE FROM A REMOVAL INSTRUMENT. THE OBSERVED BONE ATTACHMENT PROTRUDES THE SHELL'S RIM AND OVERGREWS SLIGHTLY TO THE INSIDE OF THE SHELL. THE INSIDE OF THE SHELL EXHIBITS SOME SLIGHTLY POLISHED CIRCULAR STRIPE AROUND THE POLE PLUG. WITHIN THIS STRIPE A SHINY LINE IS OBSERVABLE. SOME SLIGHT DAMAGE CAN ALSO BE OBSERVED CLOSE TO THE RIM. SCANNING ELECTRON MICROSCOPE (SEM) - BONE CEMENT: AS DESCRIBED DURING THE VISUAL EXAMINATION, THE APPEARANCE OF THE OBSERVED DEPOSITS HAS A SIMILAR APPEARANCE TO BONE OR BONE CEMENT. TO FURTHER ANALYZE THIS HYPOTHESIS SOME INDIVIDUAL REGIONS OF THE STEM TAPER WERE INVESTIGATED. A SEM TYPE JEOL JSM-6610 EQUIPPED WITH AN ENERGY DISPERSIVE X-RAY (EDX) ANALYSIS SYSTEM TYPE OXFORD INSTRUMENTS INCAWAS USED. THE PRESENCE OF A CLEAR CALCIUM PEAK IN THE EDX SPECTRA WOULD POINT TO BONE WHILE THE PRESENCE OF BARIUM OR ZIRCONIUM WOULD CLEARLY INDICATE BONE CEMENT. BONE CEMENTS ARE BASED ON SELF-POLYMERIZING POLYMETHYL METHACRYLATE ACRYLIC (PMMA). PMMA IS RADIOLUCENT AND THEREFORE SOME MANUFACTURERS ADD BARIUM SULFATE OR ZIRCONIUM OXIDE TO ACHIEVE RADIOPAQUE PROPERTIES. AN EDX ANALYSIS WAS PERFORMED IN DIFFERENT SPOTS. NO CLEAR INDICATION FOR THE PRESENCE OF BONE WAS FOUND. NEITHER BARIUM NOR ZIRCONIUM WAS DETECTED. HOWEVER, THE ABSENCE OF BARIUM AND ZIRCONIUM IN THE ANALYSIS DOES NOT EXCLUDE BONE CEMENT AS THE TYPE OF THE DEPOSIT. PRELIMINARY HYDROCHLORIC ACID AND DIETHYLENE GLYCOL MONOETHER TEST : FOR A PRELIMINARY ANALYSIS TWO TESTS WERE PERFORMED ON THE STEM TAPER TO POSSIBLY DETERMINE OR RESTRICT THE TYPE OF THE DEPOSITS. TO AVOID DAMAGE, THE STEM TAPER WAS PREVIOUSLY COVERED WITH AN ELASTIC FILM LEAVING A SMALL AREA WITH VISIBLE DEPOSITS. BONE DISSOLVES WHEN GETTING IN CONTACT WITH HYDROCHLORIC ACID. AS A CONTROL CONCENTRATED HYDROCHLORIC ACID WAS THEREFORE APPLIED WITH A COTTON SWAB AT THE DISTAL TIP OF THE STEM WHERE BONE WAS OBSERVED FOR APPROXIMATELY 10 SECONDS. THE SAME WAS DONE AT THE SMALL AREA ON THE TAPER THAT WAS NOT COVERED. THE BONE AT THE DISTAL STEM TIP WAS CLEARLY DISSOLVED WHILE ON THE STEM TAPER NO CHANGES COULD BE OBSERVED. DIETHYLENE GLYCOL MONOETHER IS A SOLVENT AND NOT COMPATIBLE WITH PMMA [1]. THEREFORE, IT CAN BE USED TO DISSOLVE BONE CEMENT. DUE TO THIS PROPERTY IT IS USED TO DETERMINE IF THE TYPE OF THE DEPOSITS COULD BE BONE CEMENT. THE SOLVENT AT 98% CONCENTRATION WAS APPLIED WITH A COTTON SWAB FOR APPROXIMATELY 10 SECONDS AT THE SMALL AREA ON THE TAPER AREA THAT WAS NOT COVERED. NO CHANGES WERE OBSERVED ON THE STEM TAPER AFTER THE TEST. -FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR): TO FURTHER INVESTIGATE THE ORIGIN OF THE WHITISH DEPOSITS ON THE TAPER AND THE WHITE-YELLOWISH DEPOSIT ON THE FACE SURFACE OF THE TAPER A FTIR ANALYSIS WAS CONSIDERED. IN ORDER TO PERFORM AN FTIR ANALYSIS, ATTEMPTS WERE MADE TO SCRAPE OFF THE WHITE-YELLOWISH DEPOSIT FROM THE TAPER'S FACE SURFACE. HOWEVER, IT WAS ONLY POSSIBLE TO SCRAPE IT OFF IN VERY FINE PARTICLES WHICH COULD NOT BE INVESTIGATED, THEREFORE THIS ANALYSIS WAS STOPPED. EXTENDED HYDROCHLORIC ACID AND DIETHYLENE GLYCOL MONOETHER TEST: AS THE FTIR ANALYSIS COULD NOT BE PERFORMED AN EXTENDED HYDROCHLORIC ACID AND DIETHYLENE GLYCOL MONOETHER TEST WAS PERFORMED. TO AVOID DAMAGE AND LEAVE DEPOSIT FOR POSSIBLE OTHER INVESTIGATIONS, THE DISTAL PART OF THE STEM TAPER WAS PREVIOUSLY COVERED WITH AN ELASTIC FILM. THE PROXIMAL PART OF THE STEM TAPER WAS FIRST SUBMERGED IN DIETHYLENE GLYCOL MONOETHER AT 98% CONCENTRATION AND HOLD IN PLACE FOR FOUR HOURS. NO CHANGES COULD BE MACROSCOPICALLY OBSERVED ON THE STEM TAPER AFTER THE TEST. AFTER THIS, THE PROXIMAL PART OF THE STEM TAPER WAS SUBMERGED FOR 2H IN A 50/50 MIXTURE OF WATER AND CONCENTRATED HYDROCHLORIC ACID. THE SUBMERGED AREA DID NOT SHOW ANY CHANGES AFTER THE TEST. PRODUCTION AND QUALITY DATA OF THE HEAD: FURTHER DOCUMENTATION WAS REQUESTED FROM THE SUPPLIER. THE FRACTURED HEAD WAS IDENTIFIED BASED ON THE FULLY VISIBLE SERIAL NUMBER AND YEAR OF PRODUCTION ON THE IMPLANT. THE PRODUCTION AND QUALITY DATA ARE WITHIN THE SPECIFICATIONS. SCANNING ELECTRON MICROSCOPE (SEM) - OXIDATION: AS THE EXTENDED HYDROCHLORIC ACID AND DIETHYLENE GLYCOL MONOETHER TEST DID NOT POINT TO BONE OR BONE CEMENT THE POSSIBILITY OF AN OXIDATION PRODUCT WAS FURTHER INVESTIGATED. THE STEM TAPER WAS ANALYZED USING THE SAME SEM AS ALREADY MENTIONED. EDX ANALYSES WERE PERFORMED ON: WHITISH DEPOSIT LAYER (ZONE 1) IN AN AREA WERE THE TAPER STRUCTURE IS NOT VISIBLE, DEPOSIT IN THE ROOTS OF THE TAPER STRUCTURE (ZONE 2), CLEAR CREST (ZONE 3). THE SPECTRA SHOWED A HIGHER CONTENT OF OXYGEN BUT A LOWER CONTENT OF TITANIUM ON THE DEPOSITS (ZONE 1 AND ZONE 2) THAN ON THE CLEAR CREST (ZONE 3). CONCLUSION: A CLOSED REDUCTION WAS PERFORMED IN (B)(6) 2018 DUE TO A TRAUMATIC DISLOCATION OF THE HIP PROSTHESIS AFTER A FALL OF THE PATIENT. TWO MONTHS LATER IN MAY THE PATIENT HAD ANOTHER DISLOCATION AND AGAIN A CLOSED REDUCTION WAS PERFORMED. SINCE THE END OF (B)(6) 2018 THE PATIENT FELT A CRACKING WITH MOVEMENT NOISE IN THE LEFT HIP WITHOUT TRAUMA AS WELL AS PAIN AND INSTABILITY. THE HIP PROSTHESIS WAS THEN REVISED AFTER APPROXIMATELY 9 YEARS AND 10 MONTHS IN VIVO DUE TO A RADIOLOGICALLY OBSERVED FRACTURE OF THE CERAMIC FEMORAL HEAD. A COMPLETE FOLLOW-UP OF THE X-RAYS DURING TIME IN VIVO IS MISSING. ONLY THE SITUATIONS AFTER THE IMPLANTATION AND AFTER THE FRACTURE ARE AVAILABLE. THE COMPARISON OF THE DIFFERENT X-RAYS DID NOT REVEAL ANY OBVIOUS CHANGES REGARDING THE BONE AND / OR COMPONENT POSITION. AT ONE POINT IN TIME THE CERAMIC HEAD FRACTURED AND THE STEM TAPER ARTICULATED DIRECTLY AGAINST THE INSERT. THIS LED TO THE STEM TAPER¿S INDENTATION AND THE ROUGHENED ARTICULATION SURFACE OF THE INSERT. OTHER CONSEQUENCES OF THE HEAD FRACTURE ARE THE SMALL CERAMIC PARTICLES EMBEDDED IN THE INSERT AND THE DAMAGE FOUND ON THE STEM¿S TAPER AND NECK REGION DUE TO THE CERAMIC FRAGMENTS RUBBING AGAINST THE STEM. THE SLIGHT YELLOWING OF THE INSERT IS DUE TO THE ABSORPTION AND POSSIBLY DIFFUSION OF ORGANIC SUBSTANCES FROM THE SYNOVIAL FLUID [2]. FURTHER SOME BACKSIDE CHANGES WERE OBSERVED WHICH COULD POINT TO MICROMOTION BETWEEN THE INSERT AND THE SHELL. THE DIRECT CONTACT OF THE STEM TAPER AND THE DIMINISHED WALL THICKNESS OF THE INSERT AFTER THE FRACTURE OF THE CERAMIC HEAD LED TO AN INCREASED COMPRESSIVE FORCE ON THE INSERT / SHELL INTERFACE. THIS RESULTED IN THE PROTRUDING IMPRESSION OF THE SHELL'S HOLE ON THE BACKSIDE OF THE INSERT. THE PART OF A SICKLE-SHAPED DEFORMED AND SLIGHTLY WORN ZONE OBSERVED IN THE HOODED AREA OF THE INSERT COULD INDICATE IMPINGEMENT. IT REMAINS UNKNOWN IF THE IMPINGEMENT OCCURRED BEFORE OR AFTER THE FRACTURE. THE HEAD TAPER SHOWS NO EVENLY DISTRIBUTED MATERIAL TRANSFER FROM THE STEM TAPER WHICH IS COMMONLY OBSERVED. THIS MATERIAL TRANSFER ON THE HEAD TAPER IS FORMED UPON INITIAL IMPACTION OF THE HEAD ON THE STEM TAPER. THEREFORE MISSING MATERIAL TRANSFER COULD INDICATE AN IMPROPER FIXATION OF THE HEAD ON THE STEM TAPER. THE LATTER COULD RESULT IN A NOT EVENLY DISTRIBUTED LOAD OVER THE HEAD TAPER. A FRACTURE OF THE CERAMIC HEAD COULD BE A POSSIBLE CONSEQUENCE. THE STEM TAPER IS HEAVILY SCRATCHED, SHOWS A WORN AREA AND SOME BLUEISH DISCOLORATION. IT ALSO EXHIBITS WHITISH DEPOSITS WHICH ARE FILLED IN MOST OF THE TAPER¿S STRUCTURE. THE DIFFERENT TESTS PERFORMED COULD EXCLUDE THAT THE BLUEISH DISCOLORATION AND THE WHITISH DEPOSITS DERIVED FROM BONE OR BONE CEMENT. BASED ON THE EDX ANALYSIS PERFORMED ON THE STEM TAPER IT IS SUPPOSED THAT THE WHITISH DEPOSITS ARE TITANIUM OXIDE. IT IS ASSUMED THAT THE BLUEISH DISCOLORATION COULD ALSO BE ASSIGNED TO OXIDATION. THIS COULD INDICATE CORROSION AT THE STEM TAPER. HOWEVER, THE REASON FOR THE CORROSION REMAINS UNKNOWN. IT COULD BE HYPOTHESIZED THAT THE FORMATION OF THE CORROSION PRODUCTS COULD LED TO AN INCREASE OF STRESS AT THE TAPER OF THE CERAMIC HEAD RESULTING IN A FRACTURE. IF AND TO WHAT EXTEND THE TRAUMATIC DISLOCATION AND THE IMPROPER FIXATION OF THE HEAD MIGHT HAVE CONTRIBUTED TO THE EVENTS LEADING TO THE FRACTURE OF THE CERAMIC HEAD STAYS UNKNOWN. [1] CHEMICAL COMPATIBILITY GUIDE DOWNLOADED FROM WWW.THERMOSCIENTIFIC.COM ON 5 NOV 2018 HTTP://TOOLS.THERMOFISHER.COM/CONTENT/SFS/BROCHURES/D20480.PDF. [2] COSTA L., BRACCO P., BRACH DEL PREVER E., LUDA M. P., TROSSARELLI L., ANALYSIS OF PRODUCTS DIFFUSED INTO UHMWPE PROSTHETIC COMPONENTS IN VIVO. BIOMATERIALS, 22, 2001, 307-315. 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.
(B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DETAIL OF PRODUCT : ASSOCIATED ITEM NUMBER: 00000004265, ITEM NAME: ALLOFT-S ALLOCLASSIC SHL 52/II, LOT #: 2452071. ASSOCIATED ITEM NUMBER: 290039090, ITEM NAME: CLS SPOTORNO, STEM, 135, UNCEMENTED, 9.0, TAPER 12/14, LOT #: 2437399. ASSOCIATED ITEM NUMBER: 0100013509, ITEM NAME: DURASUL, ALPHA INSERT, HOODED, II/32, LOT #: 2456420. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. 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. (B)(4).
IT WAS REPORTED THAT ABOUT 9 YEARS AFTER THE IMPLANTATION THE PATIENT UNDERWENT REVISION SURGERY DUE THE FRACTURE OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589959 | SULOX, HEAD, M¸ 32/0, TAPER 12/14 | N/A | KWB | ZIMMER GMBH | N/A | 2460651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |