REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140
Report
- Report Number
- 0009613350-2019-00273
- Event Type
- Injury
- Date Received
- April 29, 2019
- Date of Event
- April 1, 2019
- Report Date
- June 16, 2020
- 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
INVESTIGATION RESULTS WERE MADE AVAILABLE. D11: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEM; CATALOG#: 01.00402.065 ; LOT#: 2347864 ECHO B-MTRC MP RP SO 7; CATALOG#: 192807; LOT#: 2297657 METASUL, ALPHA INSERT, HH/28; CATALOG #: 0100010408; LOT#: 2351615 UNKNOWN CUP HIP IMPLANT; CATALOG#: UNKNOWN; LOT#: UNKNOWN. TREND ANALYSIS: NO TREND HAS BEEN IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD INITIAL THA IN 2006 AND UNDERWENT REVISION SURGERY ON (B)(6) 2019 DUE TO DISCOMFORT, DIFFICULTIES AMBULATING AND PAIN. DURING REVISION SURGERY IT WAS NOTED THAT THE PROXIMAL REVITAN COMPONENT WAS DISASSOCIATED FROM THE DISTAL REVITAN COMPONENT AND THUS WAS ABLE TO MOVE (ROTATE). REVIEW OF RECEIVED DATA: REFERRAL LETTER: IN 2006 A TOTAL HIP PROSTHESIS (THP) WAS IMPLANTED ON THE RIGHT SIDE BY DR. (B)(6) AT (B)(6) HOSPITAL. THERE WAS AN INTRAOPERATIVE COMPLICATION IN THE SENSE OF A PERIPROSTHETIC FRACTURE OR PERFORATION, AND THE HIP WAS REVISED IN FRIBOURG. THERE IS PROGRESSIVE PAIN IN THE THIGH AREA AT THE INGUINAL REGION, AND A PATHOLOGICAL GAIT PATTERN WITH AN EXTERNALLY ROTATED RIGHT LEG IS ALSO SEEN. LAST YEAR IN THE SKELETAL SCINTIGRAPHY THERE WAS A SUSPICION OF A SWINGING OF THE FEMORAL STEM WITH A STRESS REACTION DISTALLY AND THUS EXPLAINABLE PAIN. CONSULTATION REPORT ON (B)(6) 2018: DIAGNOSIS: SUSPICION OF INCIPIENT LOOSENING OF THE RIGHT HIP STEM AFTER IMPLANTATION OF A THP IN 2006 ((B)(6) HOSPITAL AND REVISION OF THE HIP PROSTHESIS ON THE SAME DAY AT (B)(6) HOSPITAL (DR. (B)(6) DUE TO A PERTROCHANTERIC FEMUR FRACTURE. SECONDARY DIAGNOSIS: OBESITY. ANAMNESIS: THE THP WAS APPARENTLY IMPLANTED ON THE RIGHT SIDE AT (B)(6) HOSPITAL IN 2006. ACCORDING TO THE PATIENT, A PERFORATION OR FRACTURE OF THE FEMUR OCCURRED, SO THAT A REVISION WAS PERFORMED THE SAME DAY AT THE (B)(6) HOSPITAL. A LONG CEMENTLESS STEM WAS IMPLANTED AND THE FRACTURE WAS FIXED WITH CERCLAGES. INITIALLY, IT WENT RELATIVELY WELL, BUT THE PATIENT NOTICED AN EXTERNAL ROTATION OF THE RIGHT FOOT. SINCE 3 YEARS INCREASING PAIN LATERALLY ABOVE THE RIGHT HIP, RADIATING VENTRALLY INTO THE THIGH. MEANWHILE THERE IS A CLEAR LIMITATION OF THE WALKING DISTANCE, OUTSIDE THE HOUSE THE PATIENT NEEDS CRUTCHES. NIGHT REST IS ACTUALLY NOT DISTURBED. THE PATIENT SUFFERS CLEARLY AFTER GETTING UP OR AFTER LONGER PERIODS OF RESTING. CONSULTATION REPORT ON (B)(6) 2018: ANAMNESIS: THE PATIENT REPORTS THAT SHE HAS HAD PAIN IN THE RIGHT HIP AREA SINCE 2015. BEFORE THIS SHE WAS PAIN-FREE FOR 9 YEARS AFTER IMPLANTATION OF THE PROSTHESIS. THE PAIN IS ALWAYS PRESENT DURING LOADING OF THE PROSTHESIS. AT REST AND AT NIGHT SHE IS PRACTICALLY FREE OF PAIN. FINDINGS: CLEARLY RIGHT-SIDED LIMPING GAIT PATTERN. EXTERNALLY ROTATED RIGHT LEG. WHEN TESTING THE ABDUCTOR FORCE IN LATERAL POSITION, IT IS CLEARLY INSUFFICIENT, THE LEG CANNOT BE HELD AGAINST GRAVITY CLEAR PAIN WHEN TESTING THE ABDUCTOR MUSCLES. X-RAYS: PELVIS AP / AXIAL VIEW OF THE RIGHT HIP DATED ON (B)(6) 2018: CORRECTLY POSITIONED TOTAL HIP PROSTHESES ON BOTH SIDES. NO SIGNS OF LOOSENING. SCINTIGRAPHY TAKEN ON (B)(6) 2017: DISCRETE RADIOLUCENT LINE IN THE PROXIMAL THIRD OF THE TOTAL HIP PROSTHESIS ON THE RIGHT SIDE. NO INDICATION OF LOOSENING, NO EVIDENCE OF AN INFECTION. ASSESSMENT AND PROCEDURE: THE PATIENT HAS A SEVERE INSUFFICIENCY OF THE GLUTEAL MUSCLES ON THE RIGHT SIDE, PROBABLY DUE TO A DETACHMENT OF THE GLUTEUS MEDIUS MUSCLE FROM THE GREATER TROCHANTER. CLINICALLY AND RADIOLOGICALLY THERE IS NO INDICATION OF A LOOSENING OF THE PROSTHESIS. MRI EXAMINATION OF THE RIGHT HIP TO ASSESS THE MUSCLE QUALITY, THE MUSCLE ORIGINS AND THE PRESENCE OF A PSEUDOTUMOUR DUE TO THE METAL-METAL PAIRING WILL BE DONE. AFTERWARDS THE FURTHER PROCEDURE WILL BE DISCUSSED AGAIN WITH THE PATIENT. CONSULTATION REPORT ON (B)(6) 2019: INTERIM ANAMNESIS: THE PATIENT COMES IN THE CLINIC TO DISCUSS THE MRI RESULTS. PAIN CONTINUES STRESS-DEPENDING. IN ADDITION, SINCE AROUND CHRISTMAS, THE RIGHT FOOT FEELS LIKE AS IT IS ON SLIPPERY ICE WHEN STANDING. AT REST THE PATIENT IS STILL FREE OF COMPLAINTS. MRI RIGHT HIP JOINT: NO SIGNS OF LOOSENING, NO INDICATION OF A PSEUDOTUMOR, NO SIGNIFICANT JOINT EFFUSION. CLEAR FATTY DEGENERATION OF THE GLUTEUS MINIMUS AND ATROPHY OF THE GLUTEUS MEDIUS. SUBCUTANEOUS ACCUMULATION OF FLUID OVER THE SURGICAL SCAR IN THE SENSE OF A SMALL SEROMA. ASSESSMENT AND PROCEDURE: THE COMPLAINTS DESCRIBED BY THE PATIENT, WHICH ARE PARTLY IMMOBILIZING, CANNOT BE CONCLUSIVELY ATTRIBUTED TO THE HIP JOINT. THE MRI ALSO SHOWS NO SIGNS OF PROSTHESIS LOOSENING. A PSEUDOTUMOR IN THE CONTEXT OF METAL WEAR AT THE METAL/METAL PAIRING CANNOT BE DETECTED. CONSULTATION REPORT ON (B)(6) 2019: ANAMNESIS: DUE TO THE PERSISTENT AND SEVERE LOAD- AND MOVEMENT DEPENDING PAIN, THE PATIENT COMES TO THE CONSULTATION. DESPITE SEVERAL CONSULTATIONS AT RENOWNED ORTHOPAEDIC SURGEONS SHE COULD NOT BE HELPED SO FAR. SHE SUFFERS THE MOST FROM THE PAIN AS SOON AS SHE PUTS WEIGHT ON HER LEG. SHE HAS NO PAIN WHEN LYING OR SITTING. DUE TO THE PAIN, HER QUALITY OF LIFE IS VERY LIMITED AND SHE CANNOT REALLY LIVE WITH IT, WHICH IS WHY SHE WOULD LIKE TO DO SOMETHING ABOUT IT. FINDINGS: MASSIVE PAIN IN THE PROXIMAL THIRD OF THE FEMUR WHEN PUSHING THE LEG. OTHERWISE INCONSPICUOUS SOFT TISSUE. ROTATION PAIN IN THE PROXIMAL THIRD OF THE FEMUR. THE SOFT TISSUES ARE OTHERWISE UNREMARKABLE. NO EVIDENCE OF A SUPERFICIAL OR DEEP NERVE LESION. REVIEW OF EXISTING SPECT-CT IMAGES, MRI AND X-RAYS: EXCEPT FOR A SLIGHT RADIOLUCENT LINE IN THE FEMUR THERE IS NO EVIDENCE OF MECHANICAL FAILURE AND A FRACTURE OF THE PROSTHESIS CANNOT BE DOCUMENTED. THE METASUL-PAIRING DOES NOT SEEM TO CAUSE ANY PROBLEMS, AS NO PSEUDOGRANULOMAS CAN BE SEEN THAT COULD LEAD TO A LOOSENING OF THE PROSTHESIS. HOWEVER, MUSCLE ATROPHIES ARE WELL DEFINABLE IN THE MRI, THEY ARE PROBABLY POSTOPERATIVE AND DID NOT OCCUR NEWLY. ASSESSMENT AND PROCEDURE: CLINICALLY, THERE IS A CLEARLY TRIGGERABLE PAIN WHICH CANNOT BE ASSIGNED TO THE MUSCLE PATHOLOGY. IT OCCURRED SUDDENLY 9 YEARS POSTOPERATIVELY WHICH WOULD INDICATE A MECHANICAL FAILURE. PREVIOUS THERAPEUTIC ATTEMPTS HAVE NOT BROUGHT ANY IMPROVEMENT. IT IS AGREED TO DO ANOTHER CT EXAMINATION TO DETERMINE WHETHER CHANGES HAVE OCCURRED IN BONE ACTIVITY 1.5 YEARS AFTER THE FIRST SCAN. IF NO NEW INFORMATION IS OBTAINED FROM THE CT, A REVISION CAN BE CARRIED OUT. IN PRINCIPLE THIS WILL BE DONE TO CHANGE THE METASUL-PAIRING TO A POLYETHYLENE AND CERAMIC ONE. DURING THE OPERATION, IT IS POSSIBLE TO ASSESS WHETHER OR NOT A PROSTHESIS FRACTURE HAS OCCURRED AFTER DEBRIDEMENT IN THE AREA OF THE STEM ENTRANCE. IF A PROSTHESIS FRACTURE IS PRESENT, THE ENTIRE STEM WOULD HAVE TO BE REMOVED VIA AN OSTEOTOMY, WHICH WOULD SIGNIFICANTLY PROLONG THE PROCEDURE. SUCH A PROCEDURE WAS DISCUSSED WITH THE PATIENT AND HER DAUGHTER. THE PATIENT IS AWARE THAT SHE MAY NOT BENEFIT FROM THE OPERATION, BUT IF COMPLICATIONS SHOULD ARISE, SHE WOULD HAVE TO BEAR THEM FULLY. THE PATIENT WISHES TO TRY THE OPERATION IN SPITE OF EVERYTHING AND SHE RESERVES AN OPERATION DATE ON (B)(6) 2019. HOWEVER, A NEW CONSULTATION WILL BE DONE AFTER RECEIVING THE SKELETAL SCINTIGRAPHY. REVISION REPORT ON (B)(6) 2019: DIAGNOSIS: PROSTHESIS FAILURE IN THE CONICAL PART OF THE REVITAN STEM. RIGHT GLUTEAL MUSCLE IMBALANCE WITH RADIANCE TO THE KNEE. STATE AFTER THP OF THE RIGHT HIP IN 2006 WITH INTRAOPERATIVE FEMUR FRACTURE AND SUBSEQUENT IMPLANTATION OF A REVISION PROSTHESIS THE SAME DAY STATE AFTER CEMENTED THR OF THE LEFT HIP IN 2009. INDICATION: FOR AN INCONSPICUOUS, OSSEOINTEGRATED PROSTHESIS THERE IS MASSIVE PAIN THAT PERSISTS OVER SEVERAL MONTHS, DEPENDING ON LOAD AND MOVEMENT. THE PAIN TENDS TO INCREASE. THE CT EXAMINATION SHOWS NO ABNORMAL FINDINGS. CLINICALLY, ROTATIONAL MOVEMENTS ARE VERY PAINFUL. THE INDICATION FOR AN EXPLORATORY REVISION OF THE PROSTHESIS IS GIVEN. THE PRIMARY AIM IS TO REPLACE THE METASUL-PAIRING. IN ADDITION IT IS NECESSARY TO EXAMINE WHETHER THERE IS A PROSTHESIS FRACTURE ON THE FEMORAL SIDE. THE ONLY INDICATION HERE IS A TILTING OF THE FEMORAL COMPONENT, WHICH IS VISIBLE IN THE X-RAY. PROCEDURE: THE RIGHT HIP JOINT IS OPENED THROUGH THE OLD SCAR. APPROACHING THE ILIOTIBIAL TRACT, A LOT OF SCAR TISSUE HAS TO BE RESECTED, PROBABLY DUE TO A LARGE SUBCUTANEOUS HEMATOMA. IN THE DISTAL TRACTUS BELOW THE TROCHANTER A LARGE TRACTUS GAP IS VISIBLE. FROM THIS GAP THE TRACTUS IS OPENED DISTALLY AND CRANIALLY, ALWAYS THROUGH THE SCAR TISSUE. ALSO IN THE GLUTEUS MAXIMUS THERE IS A FINE SECTION OF SCAR TISSUE. A LOT OF SCAR TISSUE IS EXCISED FROM ABOVE THE TROCHANTER. BELOW THE EMINENTIA INNOMINATA, THERE IS A HOLE WITH A DIRECT VIEW OF THE STEM¿S SHOULDER AND A LOT OF METALLOSIS. AT THE POSTERIOR EDGE OF THE TROCHANTER, THE SCARRED JOINT CAPSULE IS EXPOSED AND RESECTED. THE HIGHLY METALLOTIC INTRA-ARTICULAR TISSUE IS REMOVED STEP BY STEP. SAMPLES ARE SENT FOR BACTERIOLOGICAL AND HISTOLOGICAL TESTING. AN OSTEOTOMY IS PERFORMED FROM THE POSTERIOR EDGE OF THE TROCHANTER UNTIL THE LATERAL FEMORAL DEFECT. THE SHOULDER OF THE PROSTHESIS IS VERY HIGH, SO THAT THE OSTEOTOMY IS THEN COMPLETED FROM DISTAL VENTRAL TO CRANIAL, FIRST WITH THE SAW, THEN WITH THE CHISEL. THEN THE TROCHANTER IS MOVED VENTRALLY. THE TROCHANTER IS QUITE SOLID. SOME BONE HAS TO BE RESECTED ABOVE THE PROSTHESIS SHOULDER AND THEN THE FEMORAL HEAD IS DISLOCATED DORSALLY. IT IS NOW VISIBLE THAT THE PROXIMAL PART OF THE STEM CAN BE MOVED FREELY BY HAND AND THAT THE TAPER CONNECTION IS NOT STABLE ANY LONGER. THE CONICAL NUT IS REMOVED. THEN THE PROXIMAL PART CAN BE REMOVED BY HAND. THERE IS A LOT OF WEAR IN THE TAPER ON BOTH SIDES. THE FEMORAL ENTRANCE IS EXPOSED FROM THE PROXIMAL SIDE USING THE CHISEL THEN THE FEMUR IS ENTERED AT THE POSTERIOR EDGE OF THE VASTUS LATERALIS 14 CM DISTAL TO THE CONNECTION PIN. A 4.5 MM HOLE IS DRILLED AND A LONGITUDINAL CUT IS MADE WITH THE SAW, CUTTING THROUGH THE WIRE CERCLAGES. THE CERCLAGE CONNECTORS CAN BE REMOVED, BUT THE WIRES THEMSELVES CANNOT BE PULLED OUT OF THE BONE. SEVERAL ATTEMPTS ARE MADE TO MOBILIZE AND KNOCK OUT THE STEM USING VARIOUS CHISELS AND KIRSCHNER WIRES DRILLED ALONG THE STEM GROOVES. HOWEVER, IT IS STILL NOT POSSIBLE TO ACHIEVE SUFFICIENT LOOSENING OF THE STEM, SO THE FEMUR IS OSTEOTOMIZED IN A WEDGE SHAPE VIA A SECOND HOLE DISTALLY. RE-MOBILIZATION WITH CHISELS, WIRES AND HAMMERING IS PERFORMED. FINALLY, AFTER TWO HOURS THE STEM CAN BE REMOVED WITHOUT LOSS OF BONE. THE MEDULLARY CANAL IS SCRAPED WITH A SHARP SPOON AND THE DISTAL INTERMEDULLARY PEDESTAL IS DRILLED TO SIZE 12. FINALLY, THE OSTEOTOMY IS SECURED WITH TWO DOUBLE CERCLAGES. THE ACETABULUM IS COMPLETELY DEBRIDED, THE METASUL INSERT IS REMOVED AND A HIGHLY CROSSLINKED POLYETHYLENE INSERT SIZE 32 IS INSERTED. THE REMAINED BONY ANCHORING OF THE CUP IS VERY GOOD. THE FURTHER STEPS OF THE REVISION REPORT DESCRIBE THE IMPLANTATION OF A NEW EXTERNALLY ASSEMBLED REVITAN STEM CONSISTING OF A DISTAL PART SIZE 18/140 AND PROXIMAL PART SIZE 75 MM AS WELL AS A NEW BIOLOX DELTA CERAMIC HEAD SIZE 32L. X-RAYS: SIX X-RAYS TAKEN ON (B)(6) 2018 (5 AP VIEWS AND 1 SECOND VIEW) AND A MRI SCAN FROM ON (B)(6) 2019 ARE AT HAND. THE MRI SCAN WILL NOT BE FURTHER EVALUATED. THE AP VIEWS EXHIBIT DIFFERENT REGIONS OF THE PELVIS AND FEMUR. ONE AP VIEW SHOWS THE COMPLETE PROSTHESES IMPLANTED IN THE LEFT AND RIGHT HIP. ON THE RIGHT HIP SIDE A RADIOLUCENT GAP BORDERED BY A SCLEROTIC LINE ON THE BONE SIDE CAN BE SEEN ALONG THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL PART OF THE REVITAN STEM AS WELL AS PROXIMAL REGION OF THE DISTAL STEM PART. THERE ARE FOUR CERCLAGE WIRES AROUND THE FEMUR. THE PROXIMAL THREE CERCLAGES SEEM TO BE OVERGROWN BY BONE ON THE LATERAL SIDE. THE CORTICAL BONE ALONG THE LATERAL SIDE OF THE PROSTHESIS AND MEDIALLY BETWEEN THE DISTAL TWO CERCLAGES SHOWS SOME RADIOLUCENCY AND BONY REMODELING, PROBABLY DUE TO THE SITUATION AFTER THE PREVIOUS SUBTROCHANTERIC FRACTURE. AT THE DISTAL TIP OF THE PROSTHESIS AN INTRAMEDULLARY BONY PEDESTAL CAN BE SEEN. ON THE SECOND VIEW THERE SEEMS TO BE A RADIOLUCENT ZONE VISIBLE ALONG THE ANTERIOR AND POSTERIOR SIDE OF THE PROXIMAL STEM PART AS WELL AS SLIGHTLY VISIBLE SCLEROTIC LINES. DEVICES ANALYSIS: VISUAL EXAMINATION: THE EXPLANTS WERE RECEIVED IN A STERILIZATION PACKAGING. THE COLOR CODE ON THE PACKAGING INDICATES STEAM STERILIZATION. THE CONICAL NUT AND THE PROXIMAL PART OF THE REVITAN STEM WERE RECEIVED DISASSEMBLED FROM THE DISTAL PART. APART FROM SOME SCRATCHES AND ORGANIC DEPOSITS THE CONICAL NUT IS INCONSPICUOUS. THE PROXIMAL PART OF THE REVITAN STEM EXHIBITS SOME DAMAGE SUCH AS SCRATCHES AND DENTS, MOST LIKELY DERIVING FROM REVISION SURGERY. THERE ARE NO SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE. A SHINY POLISHED AREA CAN BE SEEN ON THE POSTERIOR SIDE OF THE PROXIMAL PART¿S NECK REGION. THIS IS OVERLAPPED BY A PATTERN OF PARALLEL SCRATCHES WHICH EXTENDS ON THE ENTIRE POSTERIOR SIDE OF THE PROXIMAL STEM PART. ON THE POSTEROMEDIAL SIDE OF THE STEM¿S NECK A SMALL ELLIPTICAL SHAPED WEAR MARK IS VISIBLE. IN ADDITION, DISTAL LATERAL AN AREA WITH POLISHING, WEAR MARKS AND THE PATTERN OF PARALLEL SCRATCHES CAN ALSO BE OBSERVED. ON THE INNER SIDE OF THE PROXIMAL PART, A WORN AREA CAN BE OBSERVED PROXIMAL ON THE LATERAL HALF OF THE CYLINDRICAL REGION. IN THE TAPERED REGION SOME WEAR CAN BE SEEN DISTAL MEDIAL. DISTAL LATERAL AN AREA WITH A MIXTURE OF SURFACE CHANGES RESEMBLING SURFACE DEPOSITS CAN BE SEEN. DUE TO THEIR LOCATION THEY CANNOT BE CLOSELY INSPECTED WITH THE MICROSCOPE. ON THE MEDIAL NOSE AS WELL AS ON THE ANTERIOR AND POSTERIOR SIDE OF THE FACE SURFACE OF THE PROXIMAL STEM PART WORN MARKS ARE RECOGNIZABLE. ON THE ANTEROLATERAL SIDE OF THE CYLINDRICAL REGION OF THE CONNECTION PIN A WORN AREA CAN BE SEEN. ON THE MEDIAL HALF OF THE CYLINDRICAL REGION THE ORIGINAL SURFACE WITH THE MACHINING MARKS IS STILL PRESENT. ON THE REST OF THE CYLINDRICAL REGION SOME MATERIAL SMEARING AND ORGANIC DEPOSITS CAN BE OBSERVED. THE TAPER REGION OF THE CONNECTION PIN SHOWS A MIXTURE OF POLISHING, WEAR, SMEARED MATERIAL AND ORGANIC DEPOSITS. THE POLISHING AND ORGANIC DEPOSITS EXTEND PARTIALLY DISTALLY TO THE BLASTED AREA. ON THE DISTAL PART OF THE REVITAN STEM, THERE ARE BONE ATTACHMENTS ON THE DISTAL TWO THIRDS OF THE ANCHORING SURFACE. REMOVAL DAMAGE IN THE FORM OF SCRATCHES, NICKS AND DRILL MARKS CAN BE RECOGNIZED ON THE STEM¿S ANCHORING SURFACE AS WELL AS ON THE STEM¿S FACE SURFACE. THE PROXIMAL FACE OF THE STEM BODY SHOWS WEAR MARKS ON THE ANTERIOR, POSTERIOR AND MEDIAL SIDE, CORRESPONDING TO THE DISTAL END OF THE PROXIMAL PART. DUE TO THE STEAM STERILIZATION, THE METASUL INSERT CAN BE CONSIDERED AS NO LONGER IN THE SAME CONDITION AS IMMEDIATELY AFTER ITS REMOVAL. THE CONTOUR OF THE SHELL¿S SCREW HOLES IS INDENTED ON THE ANCHORING SIDE OF THE INSERT. A SET OF SLIGHT INDENTATIONS FROM THE SHELL¿S FIXATION SPIKES AND MINUTE BACKSIDE CHANGES CAN ALSO BE OBSERVED ON THE ANCHORING SIDE. ON THE REST OF THE ANCHORING SURFACE THE MACHINING MARKS ARE VISIBLE. ON THE ARTICULATION SIDE OF THE METASUL INSERT THE MARKING ON THE POLYETHYLENE RIM IS BARELY VISIBLE. AREAS WITH SCRATCHES AND SMALL CUTS ARE ALSO NOTICEABLE ON THE POLYETHYLENE RIM, DERIVING MOST PROBABLY FROM REVISION SURGERY. THE METASUL INLAY APPEARS TO BE SLIGHTLY TILTED IN THE POLYETHYLENE LINER. NUMEROUS FINE AND SOME COARSE SCRATCHES ARE VISIBLE ON THE ARTICULATION SURFACE OF THE METASUL INLAY. UNDER CERTAIN LIGHT CONDITIONS A SLIGHT MATT AREA CAN BE RECOGNIZED ON THE ARTICULATION SURFACE. CLOSER INSPECTION OF THE INLAY WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID: WNT-03- RSR-540-151663) REVEALED THAT THE SLIGHT MATT AREA CONSISTS OF MICROPITS. IN ONE LOCATION THE BEVEL OF THE SPHERICAL CALOTTE IS WORN. ON TOP OF THE WORN BEVEL SMEARED MATERIAL CAN BE SEEN. APPROXIMATELY OPPOSITE TO THIS LOCATION A PARTIAL BORDERLINE BETWEEN THE LOADED AND UNLOADED AREA CAN BE OBSERVED ON THE SPHERICAL CALOTTE AND SOME DEPOSITS ON TOP OF THE BEVEL. ON THE ARTICULATION SURFACE OF THE METASUL HEAD THERE ARE NUMEROUS FINE AND SOME COARSE SCRATCHES. UNDER CERTAIN LIGHT CONDITIONS, A PARTIAL BORDERLINE BETWEEN THE LOADED AND UNLOADED AREA IS VISIBLE. CLOSE TO THE POLE REGION OF THE HEAD A GREYISH MATT REGION CAN BE OBSERVED. AN INVESTIGATION OF THIS REGION WITH A LOW POWER MICROSCOPE REVEALED THAT THE GREYISH MATT REGION CONSISTS OF MICROPITS. MEASUREMENTS: THE WEAR MEASUREMENTS OF THE ARTICULATION SURFACES OF THE METASUL HEAD AND METASUL ALPHA INSERT WERE CARRIED OUT ON A 3D MEASURING MACHINE TYPE CMM5, SIP GENEVA. THE ANNUAL WEAR RATE WAS CALCULATED BASED ON THE ESTIMATION THAT THE COMPONENTS WERE IMPLANTED AT LEAST 12 YEARS AND 3 MONTHS. THE TOTAL, LINEAR WEAR VALUE FOR THE HEAD IS 10.4 M WHICH RESULTS IN AN ANNUAL WEAR RATE OF 0.8 M. FOR THE INSERT THE WEAR MAP SHOWS TWO WEAR ZONES WHEREBY ONE IS LOCATED CLOSE TO THE BEVEL. COMPARING THESE WEAR ZONES TO THE ACTUAL APPEARANCE OF THE INLAY AS DESCRIBED ABOVE BOTH ZONES ARE VISIBLE ON THE ARTICULATION SURFACE. FAVORING THE WEAR ZONE CORRESPONDING TO THE PARTIAL BORDERLINE, THE TOTAL, LINEAR WEAR VALUE AMOUNTS TO 9.2 M RESULTING IN AN ANNUAL WEAR RATE OF 0.7 M. FAVORING THE WEAR ZONE CLOSE TO THE BEVEL, THE TOTAL, LINEAR WEAR VALUE AMOUNTS TO 20.6 M RESULTING IN AN ANNUAL WEAR RATE OF 1.7 M. DUE TO THE MEASURING METHOD IT IS NOT POSSIBLE TO MEASURE THE ENTIRE ARTICULATION SURFACE OF THE INSERT. THE MEASUREMENT ONLY COVERS THE SURFACE FROM THE CENTER OF THE COMPONENT UP TO 80°. THUS, DUE TO THE POSITION OF THE WEAR ZONE AT THE BEVEL IT HAS TO BE ASSUMED THAT THE WEAR AREA COULD NOT BE MEASURED ENTIRELY. THEREFORE, THE BEVEL WEAR VALUE DOES NOT REFLECT THE TRUE AMOUNT OF WEAR. FOR A METASUL PAIRING WITH DIAMETER 28 OR 32 MM RETRIEVED WITHIN THE FIRST YEAR AN AVERAGE WEAR OF 27.8 M / YEAR PER PAIRING WAS FOUND. RETRIEVALS EXPLANTED AFTER TWO AND MORE YEARS IN-VIVO HAD AN AVERAGE WEAR RATE OF 6.2 M / YEAR PER PAIRING. 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. DHR REVIEW: THE QUALITY RECORDS OF THE PROXIMAL AND THE DISTAL REVITAN COMPONENTS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION SUMMARY: ACCORDING TO THE RECEIVED INFORMATION A THP WAS APPARENTLY IMPLANTED ON THE RIGHT HIP SIDE AT (B)(6) HOSPITAL IN 2006. ACCORDING TO THE PATIENT, A PERFORATION OR FRACTURE OF THE FEMUR OCCURRED AND A REVISION WAS PERFORMED THE SAME DAY AT (B)(6) HOSPITAL. IT CAN BE ASSUMED THAT THE REVITAN STEM WAS THEN IMPLANTED AND THE FEMUR FRACTURE WAS FIXED WITH THE CERCLAGE WIRES. FROM 2015 THE PATIENT STARTED TO HAVE INCREASING PAIN LATERALLY ABOVE THE RIGHT HIP RADIATING VENTRALLY INTO THE THIGH. THE PAIN WAS ALWAYS PRESENT DURING LOADING OF THE PROSTHESIS. AT REST AND AT NIGHT THE PATIENT WAS PRACTICALLY FREE OF PAIN. SEVERAL EXAMINATIONS WERE PERFORMED BUT COULD NOT EVALUATE THE REASON FOR THE PAIN AND THERAPEUTIC MEASURES DID NOT IMPROVE THE PATIENT¿S SITUATION. CONSIDERING THE PERSISTING PAIN AND AN INCONSPICUOUS, OSSEOINTEGRATED PROSTHESIS AN INDICATION FOR AN EXPLORATORY REVISION OF THE PROSTHESIS WAS GIVEN IN 2019. THE PRIMARY AIM WAS TO REPLACE THE METASUL-PAIRING AND IN ADDITION TO EXAMINE WHETHER THERE IS A PROSTHESIS FRACTURE ON THE FEMORAL SIDE. ACCORDING TO THE REVISION REPORT, A LOT OF SCAR TISSUE WAS FOUND AND REMOVED FROM THE MUSCLES SURROUNDING THE HIP JOINT. METALLOSIS WAS ALSO SEEN AT THE STEM¿S SHOULDER. OSTEOTOMY OF THE TROCHANTER WAS PERFORMED AND THEN IT BECAME VISIBLE THAT THE PROXIMAL PART OF THE STEM COULD BE MOVED FREELY BY HAND AND THAT THE TAPER CONNECTION IS NOT STABLE ANY LONGER. THE CONICAL NUT WAS REMOVED AND THEN THE PROXIMAL PART COULD BE REMOVED BY HAND. ON THE RETRIEVALS AT HAND, BONE ATTACHMENTS COULD BE OBSERVED ON THE DISTAL PART OF THE REVITAN STEM BUT NOT ON THE PROXIMAL PART. ON THE PROXIMAL PART OF THE REVITAN STEM POLISHING AND WEAR MARKS CAN BE SEEN WHICH COULD PROBABLY INDICATE MOVEMENTS BETWEEN THE PART AND THE SURROUNDINGS (I.E. BONE, OSTEOSYNTHESIS MATERIAL). IT CAN BE ASSUMED THAT THE TAPER CONNECTION BETWEEN THE CONNECTION PIN AND THE PROXIMAL PART OF THE REVITAN STEM BECAME LOOSE. THE REASON FOR THIS LOOSENING IS UNKNOWN AND NO COMMENTS CAN BE MADE AT WHAT POINT IN TIME THE TAPER CONNECTION BECAME LOOSE. BECAUSE OF THE LOOSENING OF THE TAPER CONNECTION, MOVEMENTS BETWEEN THE PROXIMAL PART AND THE CONNECTION PIN WERE POSSIBLE. THIS RESULTED IN WEAR ON THE INSIDE OF THE PROXIMAL PART (LATERAL HALF PROXIMAL AND MEDIAL DISTAL) AS WELL AS ON THE CYLINDRICAL REGION OF THE CONNECTION PIN. THE WORN BEVEL AND THE ADJACENT SMEARED MATERIAL SEEN ON THE RIM OF THE METASUL INLAY COULD POSSIBLY POINT TO A SITUATION WHERE THE HEAD ARTICULATED IN A SUBLUXATED POSITION. THE WEAR RATE MEASURED FOR THE METASUL PAIRING IS LOW COMPARED TO. HOWEVER, DUE TO THE POSITION OF THE WEAR ZONE OF THE INLAY THE WEAR AREA CLOSE TO THE BEVEL COULD NOT BE MEASURED COMPLETELY. THE MICROPITS OBSERVED ON THE ARTICULATION SURFACES OF THE METASUL INLAY AND HEAD CAN BE ATTRIBUTED TO FATIGUE WEAR. THE WEAR THAT OCCURRED ON THE PROXIMAL PART OF THE STEM, ON THE CONNECTION PIN AND THE METASUL PAIRING PROBABLY CONTRIBUTED IN VARIOUS EXTENDS TO THE INTRA-ARTICULAR METALLOTIC TISSUE AND THE METALLOSIS WHICH WAS FOUND AND REMOVED DURING REVISION SURGERY. BASED ON RETRIEVAL INVESTIGATION AND THE RECEIVED INFORMATION IT REMAINS UNKNOWN IF AND TO WHICH EXTENT THE MUSCLE ATROPHIES, SCAR TISSUE AND LOOSENING OF THE TAPER CONNECTION OF THE REVITAN STEM CONTRIBUTED TO THE PATIENT¿S PAIN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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: 0009613350-2019-00272-1.
INVESTIGATION COMPLETED.
CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, LOT# UNKNOWN, REVITAN PROXIMAL STEM HIP IMPLANT. ITEM# UNKNOWN, LOT# UNKNOWN, REVITAN DISTAL STEM HIP IMPLANT. ITEM# UNKNOWN, LOT# UNKNOWN, UNKNOWN COCR HEAD HIP IMPLANT. ITEM# UNKNOWN, LOT# UNKNOWN, UNKNOWN INSERT HIP IMPLANT. ITEM# UNKNOWN, LOT# UNKNOWN, UNKNOWN CUP HIP IMPLANT. 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 YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. X-RAYS, SURGICAL REPORT OF REVISION AND CONSULTATION REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350 -2019-00272. 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).
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING AND WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354924 | REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140 | N/A | KWA | ZIMMER GMBH | N/A | 2324852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | SEE NARRATIVE H10 |