METASUL TAPER LINER KK/40
Report
- Report Number
- 0009613350-2017-01660
- Event Type
- Injury
- Date Received
- November 29, 2017
- Date of Event
- September 5, 2017
- Report Date
- June 29, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- PK091973
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. D11: CONCOMITANT MEDICAL PRODUCTS: REF#:00-8770-040-04, LOT#:2556889, NAME: METASUL HEAD 40 12/14 SZXL/+7 L/+7. REF#: 00875705601, LOT#: 61792926, NAME: SHELL WITH CLUSTER HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS. REF#: 00771100520, LOT # 61966455, NAME: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 5 EXTENDED OFFSET. REF#: 00625006540, LOT # 61836056, NAME: BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH. REF#: 00625006540, LOT # 61667866, NAME: BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2017-01659 (HEAD) AND 0009613350-2017-01660 (LINER). DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: THE PATIENT WAS PART OF A CONTINUUM MOM CLINICAL STUDY AND HAD A CONTINUUM CUP WITH A METASUL TAPER LINER AND METASUL HEAD IMPLANTED ON (B)(6) 2011. ON (B)(6) 2017, AT THE FOLLOW-UP VISIT OF THE STUDY, THE PATIENT REPORTED PAIN IN THE LEFT HIP. THE METAL IONS CONCENTRATION IN BLOOD WAS MEASURED ON (B)(6) 2017 AND SHOWED 34.2 G/L CO AND 18.5 G/L CR. THEN, A MARS-MRI WAS DONE WHICH SHOWED A MODERATELY LARGE LIQUID COLLECTION IN THE ILIOPSOAS REGION. IT WAS STATED THAT THIS DOES NOT FIT IN HART CLASS 1 PSEUDOTUMOR CLASSIFICATION. ACCORDING TO THE SURGEON, THIS SITUATION WAS MATCHING A REACTION TYPE ARMD AND THEREFORE THE INDICATION FOR REVISION WAS GIVEN. REVIEW OF RECEIVED DATA: ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER): THE ZPER WAS FILLED IN BY THE SURGEON AND REPORTS PAIN, WEAR AND ARMD AS REASON FOR REVISION. IN THE EVENT DETAIL SECTION THE FOLLOWING INFORMATION IS STATED: ¿ARMD, ELEVATED BLOOD METAL ION CONCENTRATIONS 21.06.17 B-CO 34.2 G/L, -CR 18.5 G/L¿. INFORMATION FROM THE REPORTER: THE REPORTER INFORMED THAT THE PATIENT PARTICIPATED IN A CONTINUUM MOM STUDY. THE PATIENT IDENTIFICATION DATA, FILLED IN ON THE FIRST PAGE OF THIS REPORT, WERE PROVIDED BY THE REPORTER AS WELL. PATIENT MEDICAL RECORDS: FOUR PAGES OF PATIENT MEDICAL RECORDS WERE RECEIVED IN FINNISH LANGUAGE. ON TOP OF THE FIRST PAGE ¿PT120¿ IS HANDWRITTEN. ONLY THE RELEVANT INFORMATION IS SUMMARIZED BELOW. (B)(6) 2017, DAILY ENTRY: LEFT CONTINUUM METAL-ON-METAL (MOM) PROSTHESIS, IMPLANTED FIVE YEARS AGO, PART OF THE CONTINUUM MOM CLINICAL STUDY. METAL IONS SLIGHTLY ELEVATED. PATIENT SCHEDULED FOR MARS-MRI STUDY AND AFTER THAT POLYCLINIC CONTROL. (B)(6) 2017, PATIENT CALL: METAL IONS CONCENTRATION ON (B)(6) 2017: ¿CO 34.2 AND CR 18.5¿. NO CHANGES WHEN COMPARING THE X-RAYS TAKEN ON (B)(6) 2015 AND (B)(6) 2017. THE MARS-MRI SHOWS ANTERIORLY IN THE ILIOPSOAS REGION A MODERATELY LARGE LIQUID COLLECTION THAT DOES NOT FIT IN HART CLASS 1 PSEUDOTUMOR CLASSIFICATION. THE PATIENT HAS A GENERAL FEELING OF DISCOMFORT, FOR WHICH NO OTHER CAUSE CAN BE FOUND. THE SYMPTOMS IN THE LEFT HIP VARY: HIGH METAL ION LEVELS IN BLOOD, LARGE INTRA-ARTICULAR LIQUID COLLECTION. THIS MATCHES A REACTION TYPE ARMD. THE PATIENT WILL BE SCHEDULED FOR REVISION IN SEPTEMBER - DECEMBER. (B)(6) 2017, TREATMENT EVALUATION: THE CUP ANTEVERSION IS ABOUT 10°. THE X-RAYS SHOW THE CUP FIRMLY ATTACHED BUT EXTENDING SLIGHTLY OVER THE EDGE OF THE ACETABULUM. PELVIS CHECK INDICATES PAIN IN THE LEFT HIP, ESPECIALLY IN THE GROIN REGION. THE PLAN IS TO REVISE THE PAIRING AND TO PREPARE FOR A CUP REVISION AS WELL. IF CLINICALLY THE CUP IS IN GOOD POSITION AND THE ILIOPSOAS DOES NOT RUB AGAINST IT, THEN ONLY A MUSCLE RELEASE AND CHANGE OF THE METAL PAIRING WILL BE MADE. (B)(6) 2017, REVISION REPORT: BEFORE OPENING THE LEFT HIP JOINT A PUNCTURE IS MADE AND ONLY 2 ML OF SOMEWHAT CLOUDY SYNOVIAL FLUID IS COLLECTED. THERE IS NO SIGNIFICANT FLUID DRAINING AFTER OPENING THE HIP JOINT, THE CAPSULE IS STILL INTACT, THE MUSCLES ARE INTACT. THERE IS A DARK BROWN DISCOLORATION OF THE SYNOVIUM. SAMPLES ARE TAKEN FOR EXAMINATION. THE JOINT IS DISLOCATED AND THE HEAD IS REMOVED. THE TAPER IS CLEAN. THE POSITION OF THE CUP IS EVALUATED; THE ANTEVERSION AND THE INCLINATION CORRESPOND TO THE X-RAY DESCRIPTIONS. THE ANTERIOR EDGE OF THE CUP EXTENDS TO SUCH EXTENT THAT IT IS UNLIKELY THAT ONLY A RELEASE OF THE ILIOPSOAS COULD BE ACHIEVED. THE LINER IS REMOVED EASILY. THE TWO SCREWS AND THE CUP¿S POLE PLUG ARE REMOVED. THE CUP IS EXTREMELY WELL FIXED. THE CUP IS REMOVED WITHOUT SIGNIFICANT BONE DAMAGE. THE POSTERIOR, ANTERIOR AND CRANIAL WALLS ARE INTACT. ANTERIORLY THERE IS SOME SYNOVIUM THICKENING AND DARK DISCOLORATION, BUT NO ACTUAL CAPSULE NECROSIS. THE REST OF THE REPORT DESCRIBES THE STEPS TO IMPLANT THE NEW HIP PROSTHESIS AND THE CLOSURE OF THE HIP. X-RAYS: 21 X-RAYS AND 209 MRI IMAGES WERE RECEIVED. THE LATTER WERE NOT EVALUATED. THE X-RAYS ARE IN JPEG FORMAT AND DATES ARE IN THE FILE NAMES. (B)(6) 2011: AP AND LATERAL VIEW: PRE-OPERATIVE X-RAYS SHOW ARTHROSIS OF THE HIP AND OSTEOPHYTE FORMATION. (B)(6) 2011: AP VIEWS: THERE IS A TOTAL HIP PROSTHESIS IMPLANTED IN THE LEFT HIP. SHELL¿S INCLINATION ANGLE CANNOT BE MEASURED AS A PELVIS OVERVIEW IS NOT AT HAND. HOWEVER, THE INCLINATION SEEMS TO BE IN NORMAL RANGE. LATERALLY, APPROXIMATELY ONE QUARTER OF THE CUP IS NOT COVERED BY BONE. THERE IS A SLIGHTLY LATERAL POSITION OF THE STEM¿S TIP WITHIN THE MEDULLARY CANAL. LATERAL VIEW: THE ANTERIOR REGION OF THE CUP EXTENDS OUTSIDE OF THE ACETABULUM AND IS NOT COVERED BY BONE. (B)(6) 2012: AP AND LATERAL VIEW :THE DISTANCE BETWEEN THE STEM¿S SHOULDER AND THE TOP OF THE TROCHANTER MAJOR WAS MARKED ON THE AP X-RAY. COMPARED WITH THE PREVIOUS STUDY DATE, A SUBSIDENCE OF THE STEM IS NOTICEABLE. (B)(6) 2012: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE. (B)(6) 2012: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE. (B)(6) 2013: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE. (B)(6) 2015: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE. (B)(6) 2017: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE. (B)(6) 2017: AP AND LATERAL VIEW: THERE ARE NO OBVIOUS CHANGES COMPARED WITH THE PREVIOUS STUDY DATE.. (B)(6) 2017: AP AND LATERAL VIEW: THE X-RAYS SHOW THE SITUATION AFTER REVISION SURGERY. IN THE AP VIEW A SUTURE ANCHOR IS PRESENT IN THE TROCHANTER MAJOR. DEVICES ANALYSIS: VISUAL EXAMINATION: THE ANCHORING SIDE OF THE METASUL TAPER LINER LOOKS INCONSPICUOUS. THERE ARE NUMEROUS FINE AND FEW COARSE SCRATCHES ON THE ARTICULATION SURFACE OF THE METASUL TAPER LINER. THE LATTER CAN PROBABLY BE ATTRIBUTED TO THE REVISION SURGERY. ON THE ARTICULATION SURFACE SEVERAL MATT AREAS CAN BE OBSERVED. AN INVESTIGATION OF THE ARTICULATION SURFACE WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID: WNT-03-RSR-540-151663) SHOWS THAT THE MATT AREAS CONSIST OF MICROPITS. THE BEVEL OF THE SPHERICAL CALOTTE IS WORN ON APPROXIMATELY 20 MM OF ITS CIRCUMFERENCE. IN THE AREA BELOW THE WORN BEVEL, THE SPHERICAL CALOTTE EXHIBITS AREAS WITH MICROPITS, PARALLEL SCRATCHES AND SMEARED MATERIAL. ON THE ARTICULATION SURFACE OF THE METASUL HEAD A PARTIAL BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREAS IS VISIBLE. CLOSE TO THIS BORDERLINE AN AREA WITH ORGANIC DEPOSITS CAN BE SEEN. CLOSE TO THE POLE THERE IS A STRIPE NOTICEABLE CONSISTING OF GREYISH SMEARED LINES AND PARALLEL SCRATCHES . ALMOST EVERYWHERE ON THE HEAD¿S ARTICULATION SURFACE, BUT MORE PREDOMINANTLY AROUND THE EQUATOR, VARIOUS SPOTS CONSISTING OF SHORT PARALLEL INDENTS CAN BE OBSERVED BY NAKED EYE. THEIR ORIGIN IS UNKNOWN. THE ARTICULATION SURFACE WAS INVESTIGATED UNDER THE MICROSCOPE (NIKON EPIPHOT EQ-ID: WNT-03-RSR-540-151662) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). AS ALREADY VISIBLE BY THE NAKED EYE, THE BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA IS WELL RECOGNIZABLE. WITHIN THE STRIPE, CLOSE TO THE POLE, VARIOUS INDENTATIONS, PARALLEL SCRATCHES AND SMEARING PATTERNS CAN BE OBSERVED. IN THE LOADED AREA FINE SCRATCHES CAN BE RECOGNIZED AND THE CARBIDES, WHICH PROTRUDED SLIGHTLY IN THE ORIGINAL SURFACE STATE, ARE LEVELED. IN THE UNLOADED AREA THE ORIGINAL SURFACE STATE WITH SLIGHTLY PROTRUDING CARBIDES IS STILL VISIBLE. ON THE HEAD TAPER, CLOSE TO THE ENTRANCE, SIGNS OF FRETTING CORROSION COULD BE FOUND. THE REASON FOR THIS PHENOMENON REMAINS UNKNOWN. WEAR MEASUREMENT: THE WEAR MEASUREMENTS OF THE ARTICULATION SURFACES OF THE METASUL HEAD AND METASUL TAPER LINER WERE CARRIED OUT ON A 3D MEASURING MACHINE TYPE CMM5, SIP GENEVA. THE TOTAL, LINEAR WEAR VALUE FOR THE HEAD IS 42.4 M WHICH RESULTS IN AN ANNUAL WEAR RATE OF 7.2 M. FOR THE LINER THE WEAR MAP SHOWS A WEAR ZONE CLOSE TO THE BEVEL. THE TOTAL, LINEAR WEAR VALUE IS 45.6 M WHICH RESULTS IN AN ANNUAL WEAR RATE OF 7.7 ¿M. DUE TO THE MEASURING METHOD IT IS NOT POSSIBLE TO MEASURE THE ENTIRE ARTICULATION SRFACE OF THE LINER. THE MEASUREMENT ONLY COVERS THE SURFACE FROM THE CENTER OF THE COMPONENT UP TO 80°. THUS, DUE TO THE POSITION OF THE WEAR ZONE IT HAS TO BE ASSUMED THAT THE WEAR AREA COULD NOT BE MEASURED ENTIRELY. THEREFORE, THE WEAR VALUE INDICATED ABOVE 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 [1]. RETRIEVALS EXPLANTED AFTER TWO AND MORE YEARS IN-VIVO HAD AN AVERAGE WEAR RATE OF 6.2 M / YEAR PER PAIRING [1]. THE PATIENT WAS PART OF A CONTINUUM MOM CLINICAL STUDY AND HAD A CONTINUUM CUP WITH A METASUL TAPER LINER AND METASUL HEAD IMPLANTED ON (B)(6) 2011. ON (B)(6) 2017, AT THE FOLLOW-UP VISIT OF THE STUDY, THE PATIENT REPORTED PAIN IN THE LEFT HIP. THE METAL IONS CONCENTRATION IN BLOOD WAS MEASURED ON (B)(6) 2017 AND SHOWED 34.2 G/L CO AND 18.5 G/L CR. THEN, A MARS-MRI WAS DONE WHICH SHOWED A MODERATELY LARGE LIQUID COLLECTION IN THE ILIOPSOAS REGION. IT WAS STATED THAT THIS DOES NOT FIT IN HART CLASS 1 PSEUDOTUMOR CLASSIFICATION. ACCORDING TO THE SURGEON THIS SITUATION WAS MATCHING A REACTION TYPE ARMD AND THEREFORE THE INDICATION FOR REVISION WAS GIVEN. BEFORE REVISION SURGERY, ONLY 2 ML OF SOMEWHAT CLOUDY SYNOVIAL FLUID WAS COLLECTED VIA A HIP PUNCTURE. UPON OPENING THE JOINT CAPSULE NO SIGNIFICANT FLUID DRAINED AND DARK BROWN DISCOLORATION OF THE SYNOVIUM WAS FOUND. SAMPLES WERE TAKEN AND SENT FOR INVESTIGATION, BUT THE RESULTS ARE NOT AT HAND. AFTER THE JOINT WAS DISLOCATED, IT WAS OBSERVED THAT THE ANTERIOR EDGE OF THE CUP EXTENDS TO SUCH EXTENT THAT ONLY A RELEASE OF THE ILIOPSOAS WOULD NOT BE ENOUGH TO PREVENT RUBBING OF THE CUP AGAINST THE MUSCLES. THEREFORE, THE CUP WAS REVISED TOGETHER WITH THE HEAD AND LINER. THE CUP¿S POSITION COULD BE ONE POSSIBLE EXPLANATION FOR THE PATIENT¿S PAIN. FROM THE X-RAY FOLLOW-UP, ONLY AP AND LATERAL X-RAYS WERE RECEIVED. WITHOUT PELVIS OVERVIEWS, THE CUP¿S INCLINATION ANGLE, DIRECTLY AFTER IMPLANTATION AND OVER THE COURSE OF TIME IN VIVO, CANNOT BE EVALUATED. WHEN COMPARING THE X-RAYS TAKEN IMMEDIATELY AFTER IMPLANTATION AND THE X-RAYS TAKEN APPROXIMATELY 2 MONTHS LATER IT CAN BE OBSERVED THAT THE STEM SUBSIDED. NO FURTHER OBVIOUS CHANGES WERE OBSERVED IN THE SUBSEQUENT X-RAYS UP TO THE POINT OF REVISION. THE APPEARANCE OF THE HEAD SURFACE WITH A STRIPE CONSISTING OF INDENTATIONS, PARALLEL SCRATCHES AND SMEARING AS WELL AS THE WORN BEVEL FOUND ON THE LINER CAN POINT TO A SUBLUXATION SITUATION. IT SEEMS THAT THE CUP¿S POSITION DOES NOT OBVIOUSLY POINT TO A SITUATION THAT WOULD TRIGGER A SUBLUXATED HEAD POSITION CAUSING RIM LOADING. THEREFORE, IT IS HYPOTHESIZED THAT THE SUBSIDENCE OF THE STEM LED TO A LAXITY OF THE JOINT THAT ENABLED A MICROSEPARATION DISPLACEMENT BETWEEN THE ARTICULATING COMPONENTS [2]. MICROSEPARATION MEANS THAT THE HEAD IS RECURRENTLY IN CONTACT WITH THE RIM OF THE LINER. THIS RESULTED IN AN ELEVATED WEAR RATE FOR BOTH COMPONENTS THAT COULD EXPLAIN THE REPORTED ELEVATED CO AND CR LEVELS. HOWEVER, THE FRETTING CORROSION SEEN ON THE HEAD TAPER SURFACE COULD BE ANOTHER POSSIBLE SOURCE FOR THE ELEVATED METAL IONS IN BLOOD. [1] RIEKER CB, SCHOEN R, KOETTIG P, SHEN M, KREVOLIN J, 2006, IN-VITRO VERSUS IN-VIVO ANALYSIS OF METAL-ON-METAL ARTICULATIONS, ABSTRACT 7892 OF THE 5TH WORLD CONGRESS OF BIOMECHANICS, JUL 29-AUG 4, MUNICH, GERMANY, JOURNAL OF BIOMECHANICS 2006; VOL. 39 SUPPL. 1, P. 120. [2] FENG L, SOPHIE W, JOHN F, EFFECT OF MICROSEPARATION ON CONTACT MECHANICS IN METAL-ON-METAL HIP REPLACEMENTS - A FINITE ELEMENT ANALYSIS, J BIOMED MATER RES PART B 2015:103B:1312¿1319. 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). THIS IS A SPLITCASE WITH ZIMMER INC, WARSAW REFERENCE NUMBER (B)(4) (MFR 0001822565-2017-08027).
THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL TAPER LINER KK/40 ON THE LEFT SIDE ON (B)(6) 2011 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO ELEVATED METAL IONS, PAIN, WEAR AND ARMD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 846686 | METASUL TAPER LINER KK/40 | METASUL TAPER LINER KK/40 | KWA | ZIMMER GMBH | N/A | 2556811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |