METASUL, ALPHA INSERT, JJ/28
Report
- Report Number
- 0009613350-2019-00037
- Event Type
- Injury
- Date Received
- February 4, 2019
- Date of Event
- December 14, 2018
- Report Date
- August 14, 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
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DETAIL OF PRODUCT: ITEM# 0100024454, LOT# 2049652, FITMORE, SHELL WITH FINS, UNCEMENTED, 54/JJ. ITEM#UNKNOWN, ITEM NAME ALLOCLASSIC ZWEYMULLER CFS STEM HIP IMPL WIN GEN, LOT # UNKNOWN. 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: OSTEOLYSIS AND WEAR. EVENT DESCRIPTION: BESIDES THE PATIENT INFORMATION ALREADY MENTIONED ON THE FRONT PAGE OF THIS REPORT, THE FOLLOWING ADDITIONAL INFORMATION CAN BE SUMMARIZED FROM THE SURGEON¿S LETTER. IN 2001 (IMPLANTATION REPORT IS NOT AVAILABLE) THE PATIENT RECEIVED A TOTAL HIP PROSTHESIS (THP) IN THE LEFT HIP (FITEK CUP, METASUL INSERT, METASUL HEAD 28 MM, ALLOCLASSIC ZWEYMÜLLER STEM). REVIEW OF RECEIVED DATA: COURSE: DEVELOPMENT OF COGNITIVE DISABILITIES FROM 2016. ON (B)(6) 2016 THE PATIENT HAD AN NON-DISPLACED PERIPROSTHETIC ACETABULAR FRACTURE OF THE POSTERIOR COLUMN, TYPE UCS B1. BLOOD TESTS FROM (B)(6) 2018 (NO PREVIOUS RESULTS): CR 29.1 G/L AND CO 73.5 G/L. ON (B)(6) 2018 THE PATIENT HAD A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE, TYPE UCS B1. REVISION: SUSPECTED DIAGNOSIS: CHROMIUM- UND COBALT INTOXICATION AND SYMPTOMATIC OSTEOLYSIS OF THE ACETABULUM. THE CUP HAD TO BE CUT WITH THE SPHERICAL CHISELS, WHICH WAS RELATIVELY EASY DUE TO A VERY SOFT BONE AND OSTEOLYSIS. THE INSERT WAS NOT DISASSEMBLED FROM THE SHELL. BECAUSE OF OSTEOLYTIC BONE DEFECTS A RECONSTRUCTION WITH AN OVERSIZED BURCH REINFORCEMENT RING HAD TO BE DONE. THE STEM WAS PRESERVED BECAUSE IT WAS MOSTLY FIXED, THE PATIENT IS ELDERLY AND THE NOTCH ON THE POSTERIOR TAPER WAS BARELY VISIBLE. OTHERWISE THE TAPER HAD NO WEAR, THE CIRCULAR GROOVES WERE PRESERVED. ON THE EXPLANT IT CAN BE OBSERVED THAT THE INSERT WOBBLES. HISTOPATHOLOGY TESTING SHOWS RELATIVELY FEW METAL WEAR PARTICLES. HOWEVER, THERE IS A NECROSIS IN THE TISSUE AND A PRONOUNCED PERIVASCULAR LYMPHOPLASMOCYTIC REACTION BELOW, BOTH CAN BE INTERPRETED AS INDUCED BY METAL DEBRIS. NO POLYETHYLENE WEAR COULD BE DETECTED. REPORT OF REVISION SURGERY PERFORMED ON (B)(6) 2018. DIAGNOSIS: SYMPTOMATIC REACTION TO METAL WEAR AND OSTEOLYSIS OF THE LEFT HIP ACETABULUM, WITH: EXCESSIVE CUP INCLINATION AFTER IMPLANTATION OF A UNCEMENTED THP IN 2001 (TRANSGLUTEAL WITH METAL-ON-METAL PAIRING). STATE AFTER NON-DISPLACED PERIPROSTHETIC ACETABULAR FRACTURE OF THE POSTERIOR COLUMN, TYPE UCS B1 ON (B)(6) 2016. STATE AFTER PERIPROSTHETIC PROXIMAL FEMUR FRACTURE TYPE UCS B1 ON (B)(6) 2018. INDICATION: SEE DIAGNOSIS. DUE TO A MALPOSITIONING OF THE CUP WITH AN INCLINATION OF 63° THE OPTION TO ONLY CHANGE THE INSERT IS DISCARDED. IN ADDITION, THERE IS QUESTIONABLE SYMPTOMATIC OSTEOLYSIS OF THE ACETABULUM AND THEREFORE THE CUP IS REVISED. PROCEDURE: THE HIP JOINT IS OPENED. THE CAPSULE, ABOUT 15 MM THICK, IS PROGRESSIVELY OPENED. A MILKY GRAYISH EFFUSION DRAINS. THERE IS A PRONOUNCED CHRONIC SYNOVITIS WITH A MODERATE METALLOSIS. THE HEAD IS REMOVED. THE TAPER SHOWS CORROSION IN THE CONTACT AREA, HOWEVER THE GROOVES ARE STILL PRESERVED AND THERE IS NO LOSS OF MATERIAL. THE FEMUR IS PROGRESSIVELY ROTATED AND THE ACETABULUM IS EXPOSED. THE OSTEOLYSIS IS CURETTED AT THE ENTRANCE TO THE FEMORAL METAPHYSIS. THE STEM IS FIRMLY FIX. THE CUP IS CUT WITH SPHERICAL CHISELS UNTIL IT IS COMPLETELY RELEASED FROM THE BONE. THE BONE IS VERY SOFT. THE CUP WAS STILL OSSEOINTEGRATED AND THE CUT HAS CAUSED ALMOST NO LOSS OF BONE SUBSTANCE. THERE IS HOWEVER LARGE OSTEOLYSIS IN THE ACETABULUM. ESPECIALLY AT THE LAMINA QUADRILATERALIS THERE IS A BONE DEFECT OF ABOUT 20 MM IN DIAMETER. THE ANTERIOR AND THE POSTERIOR ACETABULAR WALL CAN NO LONGER BE IDENTIFIED. HOWEVER, THE CONTINUITY OF THE PELVIS IS MAINTAINED. THE ISCHIUM ALSO SHOWS LARGE OSTEOLYSIS BUT THE CORTICAL BONE IS STILL PRESERVED. THE OSTEOLYSIS IS CURETTED. SAMPLES WERE TAKEN FROM THE CAPSULE AND THE OSTEOLYSIS FOR MICROBIOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION. THE REST OF THE REVISION REPORT DESCRIBES THE STEPS USED TO PREPARE THE ACETABULUM TO IMPLANT A BURCH REINFORCEMENT RING SIZE 56, A CEMENTED MÜLLER LOW PROFILE CUP SIZE 56/36 AND A BIOLOX OPTION HEAD 36/XL. X-RAYS: DUE TO THE DIFFERENCES IN CONTRAST AND BRIGHTNESS AS WELL AS SLIGHT CHANGES OF THE PATIENT¿S POSITION IN SOME OF THE X-RAYS IT IS DIFFICULT TO DETERMINE IF CHANGES ARE ACTUALLY PRESENT. EXAMINATION OF MANUFACTURING DOCUMENTS: THE MANUFACTURING DOCUMENTS WERE INSPECTED AND THE INFORMATION ABOUT THE PRODUCTION AND THE EXPIRY DATE OF THE RETRIEVALS AT HAND IS LISTED IN TABLE 1. BASED ON THIS AND THE DATE OF THE FIRST X-RAY THAT SHOWS THE IMPLANTED COMPONENTS (B)(6) 2001) A TIME IN VIVO OF AT LEAST 17 YEARS AND 7 MONTHS CAN BE ESTIMATED. DEVICE ANALYSIS: VISUAL EXAMINATION: IN THE AS RECEIVED CONDITION THE METASUL ALPHA INSERT WAS STILL ASSEMBLED IN THE FITMORE SHELL. IT COULD BE OBSERVED THAT THE INSERT HAD A SLIGHT ROTATIONAL PLAY IN THE SHELL IN THE CLOCKWISE - COUNTERCLOCKWISE DIRECTION. DURING THE HANDLING STEPS OF THE CLEANING AND DISINFECTION PROCESS (SOAKING IN VARIOUS CLEANING AND DISINFECTION DETERGENTS) THE INSERT BECAME FREE FROM THE SHELL WITHOUT PUTTING ANY EFFORT TO REMOVE IT. BROWNISH ORGANIC DEPOSITS WERE OBSERVED ON THE BACKSIDE OF THE INSERT AND ON THE INNER SIDE OF THE SHELL. THE FITMORE SHELL SHOWS DAMAGE FROM REVISION SURGERY IN THE FORM OF SCRATCHES AND INSTRUMENT MARKS ALONG THE EQUATOR REGION OF THE SULMESH COATING. THERE ARE BONE ATTACHMENTS VISIBLE ON THE ANCHORING SIDE OF THE SHELL. NUMEROUS SMALL LINE-SHAPED, SHINY POLISHED AREAS CAN BE SEEN ON THE INNER SIDE OF THE SHELL INCLUDING THE REGION OF THE SNAP FIT. THESE SHINY POLISHED AREAS ARE DENSER ON THE INNER HALF WHERE THE TWO FINS ARE LOCATED. ON THE ARTICULATION SIDE OF THE METASUL ALPHA INSERT THE POLYETHYLENE RIM EXHIBITS AN AREA WITH SLIGHT ABRASION. WITHIN THIS AREA SMALL WHITISH ZONES AND A CRACK CAN BE SEEN IN THE POLYETHYLENE. AREAS WITH SCRATCHES AND SMALL CUTS ARE ALSO NOTICEABLE AROUND THE POLYETHYLENE RIM, DERIVING MOST PROBABLY FROM REVISION SURGERY. 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: (B)(4) REVEALED THAT THE SLIGHT MATT AREA CONSISTS OF MICROPITS. IN ONE LOCATION THE BEVEL OF THE SPHERICAL CALOTTE IS WORN ON APPROXIMATELY 15 MM OF ITS CIRCUMFERENCE. ON THE ADJACENT SPHERICAL CALOTTE AN AREA WITH PITS ARRANGED IN ARROW-SHAPED FORMATIONS CAN BE SEEN. APPROXIMATELY OPPOSITE TO THIS LOCATION ANOTHER AREA WITH ARROW-SHAPED FORMATIONS AND AN AREA WITH MICROPITS CAN BE OBSERVED ON THE SPHERICAL CALOTTE. BETWEEN POSITION 1 AND 2 SMEARING CAN BE RECOGNIZED ON THE BEVEL CLOSE TO THE SPHERICAL CALOTTE. CLOSE TO POSITION 2 THERE SEEMS TO BE A DIFFERENT SMEARING ON TOP OF THE BEVEL, CLOSE TO THE POLYETHYLENE. ON THE ANCHORING SIDE OF THE INSERT THERE IS A SET OF INDENTATIONS FROM THE SHELL¿S FIXATION SPIKES . THESE INDENTATIONS ARE SLIGHTLY ENLARGED. ON ONE SIDE OF THE INSERT THERE ARE TWO ELLIPSE-SHAPED PROTRUSIONS. THE PROTRUSIONS DERIVED FROM THE TWO ANCHORAGE AREAS OF THE SHELL¿S FINS. THE FACE SURFACE OF THESE PROTRUSIONS STILL EXHIBITS THE ORIGINAL SURFACE WITH THE MACHINING MARKS. ON ALMOST THE ENTIRE ANCHORING SIDE, BACKSIDE CHANGES CAN BE SEEN. IN ONE LOCATION, OPPOSITE TO THE TWO ELLIPSE-SHAPED PROTRUSIONS SOME MACHINING MARKS REMAINED VISIBLE. THE POLE PIN SHOWS ABRASIVE DAMAGE. THE SNAP FIT REGION SEEMS TO BE INCONSPICUOUS. ON THE ARTICULATION SURFACE OF THE METASUL HEAD A GREYISH MATT REGION IS VISIBLE. WITHIN THIS REGION A SICKLE-SHAPED AREA WITH PARALLEL SCRATCHES CAN BE OBSERVED WITH THE UNAIDED EYE. THE ARTICULATION SURFACE WAS FURTHER INVESTIGATED UNDER THE MICROSCOPE (NIKON EPIPHOT EQ-ID: (B)(4) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). WITHIN THE GREYISH MATT REGION MICROPITS AND SMEARING CAN BE OBSERVED. IN THE SICKLE-SHAPED AREA PARALLEL SCRATCHES AND SMEARED MATERIAL CAN BE SEEN. IN ONE LOCATION, CLOSE TO THE SICKLE-SHAPED AREA THERE ARE PITS FORMING ARROW- SHAPED FORMATIONS. IN THE LOADED AREA THAT DOESN¿T APPEAR GREYISH MATT, FINE SCRATCHES CAN BE RECOGNIZED AND THE CARBIDES, WHICH PROTRUDED SLIGHTLY IN THE ORIGINAL SURFACE STATE, ARE LEVELED. THE ORIGINAL SURFACE STATE WITH SLIGHTLY PROTRUDING CARBIDES IS STILL VISIBLE IN THE UNLOADED AREA. ON THE HEAD TAPER SIGNS OF CORROSION COULD BE FOUND. THE REASON FOR THIS PHENOMENON REMAINS UNKNOWN. WEAR MEASUREMENT: THE WEAR MEASUREMENT 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 TOTAL, LINEAR WEAR VALUE FOR THE HEAD IS 83.8 M WHICH RESULTS IN AN ANNUAL WEAR RATE OF 4.8 . FOR THE INSERT THE WEAR MAP SHOWS A WEAR ZONE CLOSE TO THE BEVEL. THE TOTAL, LINEAR WEAR VALUE IS 135.8 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 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 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]. 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. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). CONCLUSION: IN 2001 THE PATIENT RECEIVED A THP IN THE LEFT HIP (FITMORE CUP, METASUL INSERT, METASUL HEAD AND ALLOCLASSIC ZWEYMÜLLER STEM). AFTER AT LEAST 17 YEARS AND 7 MONTHS IN VIVO THE CUP, THE INSERT AND THE HEAD WERE REVISED DUE TO SYMPTOMATIC REACTION TO METAL WEAR AND OSTEOLYSIS OF THE LEFT HIP ACETABULUM. ON THE FIRST X-RAY SHOWING THE IMPLANTED COMPONENTS (B)(6) 2001) THE CUP HAD AN INCLINATION ANGLE OF APPROXIMATELY 63°. AT LEAST STARTING FROM (B)(6) 2006 FORMATION OF RADIOLUCENT AREAS AROUND THE CUP AND IN THE PROXIMAL REGION OF THE FEMUR COULD BE SEEN. THE RADIOLUCENCY COULD BE INTERPRETED AS OSTEOLYSIS AND PROGRESSED OVER TIME IN VIVO FOR BOTH THE ACETABULAR AND PROXIMAL FEMUR REGIONS. HOWEVER NO CHANGE IN CUP OR STEM POSITION COULD BE OBSERVED. THE APPEARANCE OF THE CUP DOES NOT POINT TO LOOSENING. THE CUP SHOWS BONE ONGROWTH ON THE ANCHORING SURFACE AND NO SIGNS OF LOOSENING. THE X-RAY FOLLOW-UP EXHIBITS ALSO A PERIPROSTHETIC FRACTURE OF THE ACETABULUM IN (B)(6) 2016 AND A PERIPROSTHETIC FEMUR FRACTURE IN (B)(6) 2017. THE LATTER WAS REPORTED BOTH IN THE SURGEON¿S LETTER AND IN THE REVISION REPORT TO HAVE OCCURRED IN (B)(6) 2018 WHICH PROBABLY IS A TYPO. THERE IS NO INFORMATION AT HAND ON THE CIRCUMSTANCES THAT LED TO THESE FRACTURES. DUE TO THE MALPOSITIONING OF THE CUP (HIGH INCLINATION ANGLE OF APPROXIMATELY 63°) IT CAME TO A SITUATION WHERE THE METASUL HEAD COULD ARTICULATE IN A SUBLUXATED POSITION IN THE METASUL INLAY. AS A CONSEQUENCE A RIM LOADING SITUATION DEVELOPED WHICH LED TO THE WORN BEVEL ON THE INLAY AND TO THE SICKLE-SHAPED AREA WITH PARALLEL SCRATCHES ON THE ARTICULATION SURFACE OF THE HEAD. THIS LED TO AN INCREASED WEAR RATE COMPARED TO [1]. HOWEVER, IT HAS TO BE MENTIONED THAT DUE TO THE POSITION OF THE WEAR ZONE OF THE INLAY THE WEAR AREA COULD NOT BE MEASURED ENTIRELY. THE ELEVATED WEAR RATE COULD PROBABLY EXPLAIN THE REPORTED ELEVATED CO AND CR LEVELS IN THE PATIENT¿S BLOOD AND THE MODERATE METALLOSIS OBSERVED DURING REVISION SURGERY. THE SMEARING ON TOP OF THE BEVEL CLOSE TO THE POLYETHYLENE AS WELL AS THE ABRASION SEEN ON THE RIM OF THE POLYETHYLENE COULD POINT TO AN IMPINGEMENT BETWEEN THE STEM NECK AND THE METASUL INSERT. IN HIS LETTER, THE SURGEON STATES THAT A SMALL NOTCH ON THE POSTERIOR STEM TAPER WAS BARELY VISIBLE WHICH COULD CONFIRM THAT A SLIGHT IMPINGEMENT OCCURRED. IT SEEMS THAT THIS IMPINGEMENT DID NOT RESULT FROM THE HIGH INCLINATION OF THE CUP BUT RATHER FROM SOME RARE SITUATIONS WHERE A RANGE OF MOTION LARGER THAN USUAL FOR THE PATIENT WAS NECESSARY. ACCORDING TO [2] THE SIZE OF THE MICROPITS OBSERVED ON THE METASUL PAIRING IS IN THE RANGE OF 1 - 2 M IN DIAMETER AND UP TO 0.5 M IN DEPTH. THE MICROPITS AND THE ARROW-SHAPED FORMATIONS CAN BE ATTRIBUTED TO SURFACE FATIGUE [2]. THE SMALL WHITISH ZONES AND THE CRACK ON THE POLYETHYLENE LINER ARE SIGNS OF MATERIAL EMBRITTLEMENT DUE TO OXIDATION. THE SMALL LINE-SHAPED, SHINY POLISHED AREAS SEEN ON THE INSIDE OF THE SHELL AND THE BACKSIDE CHANGES ON THE ANCHORING SIDE OF THE INSERT INDICATE MICROMOTION BETWEEN THE TWO COMPONENTS. THE SLIGHTLY ENLARGED INDENTATIONS FROM THE SHELL¿S FIXATION SPIKES AND THE ELLIPSE-SHAPED PROTRUSIONS INDICATE A SLIGHT ROTATION OF THE INSERT IN THE SHELL. AT WHAT POINT IN TIME THE INSERT STARTED TO SLIGHTLY ROTATE STAYS UNKNOWN. CONSIDERING THE OVERALL SITUATION, IT COULD BE HYPOTHESIZED THAT THE SUBLUXATING SITUATION AND RESULTING RIM LOADING DESCRIBED EARLIER POSSIBLY LED TO SUBOPTIMAL LUBRICATION, WHICH RESULTED IN HIGHER THAN NORMAL FRICTION MOMENTS BETWEEN THE ARTICULATING COMPONENTS. IT COULD BE SUSPECTED THAT THIS COULD HAVE HAD AN INFLUENCE ON THE ROTATION STABILITY OF THE INSERT OVER TIME IN VIVO. IT IS POSSIBLE THAT ALSO OTHER FACTORS NOT MENTIONED ABOVE COULD HAVE HAD AN INFLUENCE ON THE ROTATIONAL PLAY OF THE INSERT IN THE SHELL. IT STAYS UNKNOWN IF AND TO WHICH EXTEND ANY OF THE ABOVE MENTIONED FINDINGS (INCREASED WEAR RATE, SIGNS OF CORROSION ON THE HEAD TAPER, BACKSIDE CHANGES ON THE ANCHORING SIDE OF THE INSERT, IMPINGEMENT BETWEEN THE STEM NECK AND THE INSERT) COULD HAVE CONTRIBUTED TO THE OSTEOLYSIS AROUND THE CUP AND IN THE PROXIMAL REGION OF THE FEMUR. REFERENCES: [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] C. B. RIEKER, P. KÖTTIG, R. SCHÖN, M. WINDLER, U.P. WYSS. CLINICAL TRIBOLOGICAL PERFORMANCE OF 144 METAL-ON-METAL HIP ARTICULATIONS, METASUL: A METAL-ON-METAL BEARING, HUBER 1999. 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).
PLEASE REFER TO REPORT 0009613350-2019-00037.
CONCOMITANT MEDICAL PRODUCTS: ITEM# 192807, LOT# 2055484, ECHO B-MTRC MP RP SO 7. ITEM# UNKNOWN, LOT# UNKNOWN, FITEK SHELL 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 K993259. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. X-RAYS AND SURGICAL REPORT WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT 0009613350-2019-00038.
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY SEVENTEEN YEARS POST IMPLANTATION DUE TO ELEVATED METAL IONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95077 | METASUL, ALPHA INSERT, JJ/28 | N/A | KWA | ZIMMER GMBH | N/A | 2043654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |