METASUL, HEAD, M, 32/0, TAPER 12/14

Report

Report Number: 0009613350-2018-00339
Event Type: Injury
Date Received: March 12, 2018
Date of Event: February 13, 2018
Report Date: September 7, 2018
Manufacturer: ZIMMER GMBH
Product Code: LZO
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: HE 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: REVISION DUE TO METALOSIS, PAIN. EVENT DESCRIPTION: THE ALLOFIT SHELL, THE METASUL ALPHA INSERT AND THE METASUL HEAD WERE REVISED AFTER 9 YEARS AND 3 MONTHS IN VIVO DUE TO PAIN, METALLOSIS AND FLUID COLLECTION. REVIEW OF RECEIVED DATA: PRODUCT EXPERIENCE REPORT (PER). THE PER (PERFECT, SALESFORCE FORM) WAS FILLED IN BY THE SALES REPRESENTATIVE AND IN THE EVENT DESCRIPTION SECTION IT IS STATED THAT: ¿THE PATIENT HAS A COLLECTION OF FLUID AND PAIN¿. AS REASON FOR REVISION ¿METALOSIS¿ IS GIVEN. IN THE ADDITIONAL COMMENTS SECTION THE FOLLOWING ARE MENTIONED: ¿NOT DECONTAMINATED, SURGEON THINKS IT¿S TRUNIONOSIS AND WOULD LIKE BEARING ASSESSED¿. X-RAYS: TWO X-RAYS (AP VIEW OF THE LEFT HIP AND SECOND VIEW) TAKEN ON (B)(6) 2018 WERE RECEIVED. THEY SHOW A HIP PROSTHESIS WITH METAL ON METAL BEARING IMPLANTED IN THE LEFT HIP. SHELL¿S INCLINATION ANGLE CANNOT BE MEASURED AS A PELVIS OVERVIEW IS NOT AT HAND. THE AP VIEW SHOWS SMALL RADIOLUCENT AREAS AROUND THE STEM¿S TIP, THE STEM¿S LATERAL SIDE AND THE STEM¿S LATERAL SHOULDER. ON THE SECOND VIEW RADIOLUCENT AREAS ARE VISIBLE AROUND THE STEM¿S TIP AND ON THE POSTERIOR SIDE OF THE STEM. A RADIOLUCENT LINE IS SEEN ALONG THE ANTERIOR SIDE OF THE STEM AT THE CEMENT/BONE INTERFACE. DEVICE ANALYSIS: VISUAL EXAMINATION: IN THE AS-RECEIVED CONDITION THE METASUL ALPHA INSERT WAS STILL IN THE ALLOFIT SHELL . IT WAS OBSERVED THAT THE INSERT WAS IN A SLIGHTLY OUTWARD POSITION FROM THE SHELL AND IT CAME OUT EASILY. DRY BROWNISH ORGANIC DEPOSITS WERE OBSERVED ON THE BACKSIDE OF THE INSERT AND ON THE INNER SIDE OF THE SHELL. THE ALLOFIT SHELL SHOWS SLIGHT DAMAGE FROM REVISION SURGERY IN THE FORM OF SCRATCHES ON THE RIM AND ON THE ANCHORING SIDE. THERE ARE BONE ATTACHMENTS VISIBLE ON THE ANCHORING SIDE OF THE SHELL . SOME OF THE TEETH OF THE SHELL¿S MACROSTRUCTURE APPEAR TO BE SLIGHTLY POLISHED. ON THE INNER SIDE OF THE SHELL TINY POLISHED SPOTS CAN BE SEEN AROUND THE POLAR SCREW. A MARK FROM THE SETTING INSTRUMENT AND A PERPENDICULAR SMALL SCRATCH CAN BE OBSERVED IN THE POLE REGION. THE METASUL ALPHA INSERT SHOWS DAMAGE ON THE POLYETHYLENE RIM IN THE FORM OF SCRATCHES, MOST PROBABLY MADE DURING REVISION SURGERY. ON TWO OPPOSING HOLES FOR THE SETTING INSTRUMENT INDENTED MARKS CAN BE OBSERVED. NUMEROUS FINE SCRATCHES ARE VISIBLE ON THE ARTICULATION SURFACE OF THE METASUL INLAY. AN INVESTIGATION OF THE INLAY WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID: WNT-03- RSR-540-151663) REVEALED A REGION WITH SMEARED LINES PERPENDICULAR TO THE RIM AND A SMALL AREA WITH MICROPITS ON THE ADJACENT SPHERICAL CALOTTE. APPROXIMATELY OPPOSITE TO THIS REGION, THERE IS A SMALL AREA WITH SMEARED MATERIAL ON THE INLAY¿S RIM AS WELL AS FEW SCRATCHES ON THE ADJACENT SPHERICAL CALOTTE AND POLYETHYLENE RIM . ON THE ANCHORING SIDE OF THE INSERT, THERE IS A SET OF INDENTATIONS FROM THE SHELL¿S FIXATION SPIKES. ON THE ENTIRE ANCHORING SURFACE THE MACHINING MARKS ARE STILL VISIBLE AND ONLY SLIGHT BACKSIDE CHANGES CAN BE OBSERVED IN THE AREA AROUND THE POLE PIN. THE LATTER IS INTACT. THE INDENTATIONS FROM THE SHELL¿S FIXATION SPIKES AND THE INTACT POLE PIN INDICATE A PROPER FIXATION OF THE INSERT IN THE SHELL. AROUND THE EQUATOR A MIXTURE OF POLISHED AND ROUGH WAVY STRUCTURE IS SEEN OVERLAID ON THE MACHINING MARKS. IN ADDITION, ON THE LATERAL EDGE OF THE POLYETHYLENE, PROXIMAL TO THE SNAP FIT MECHANISM, THE POLYETHYLENE IS SLIGHTLY DEFORMED INWARDS SO THAT A NEW LEDGE IS SEEN AROUND THE ENTIRE CIRCUMFERENCE. ON THE ARTICULATION SURFACE OF THE METASUL HEAD THERE ARE NUMEROUS FINE AND SEVERAL COARSE SCRATCHES. ON ONE SIDE OF THE HEAD AN AREA WITH DENSE SCRATCHES CAN BE OBSERVED. THE ARTICULATION SURFACE WAS INVESTIGATED UNDER THE LIGHT MICROSCOPE (NIKON EPIPHOT, EQ-ID: WNT-03-RSR-540-151662) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). IN THE LOADED AREA FINE SCRATCHES CAN BE RECOGNIZED AND THE CARBIDES, WHICH PROTRUDED SLIGHTLY IN THE ORIGINAL SURFACE STATE, ARE LEVELED. IN THE AREA WITH DENSE SCRATCHES, SLIGHT INDENTATIONS COULD ALSO BE OBSERVED. IN THE UNLOADED AREA THE ORIGINAL SURFACE STATE WITH SLIGHTLY PROTRUDING CARBIDES IS STILL VISIBLE. ON THE HEAD TAPER SIGNS OF FRETTING CORROSION COULD BE FOUND. WEAR MEASUREMENT: 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 TOTAL, LINEAR WEAR VALUE FOR THE HEAD IS 3.5 M WHICH RESULTS IN AN ANNUAL WEAR RATE OF 0.4 MICRO. IT WAS NOT POSSIBLE TO IDENTIFY A CLEAR WEAR ZONE FOR THE METASUL INSERT AND THEREFORE A WEAR VALUE COULD NOT BE DETERMINED. HOWEVER, THE MEASURED DIAMETER IS STILL WITHIN THE MANUFACTURING TOLERANCES. FOR A METASUL PAIRING WITH DIAMETER 28 OR 32 MM RETRIEVED WITHIN THE FIRST YEAR AN AVERAGE WEAR OF 27.8 MICRO / YEAR PER PAIRING WAS FOUND. RETRIEVALS EXPLANTED AFTER TWO AND MORE YEARS IN-VIVO HAD AN AVERAGE WEAR RATE OF 6.2 MICRO / YEAR PER PAIRING. CONCLUSION: THE ALLOFIT SHELL, THE METASUL ALPHA INSERT AND THE METASUL HEAD WERE REVISED AFTER 9 YEARS AND 3 MONTHS IN VIVO. IT IS SUPPOSED THAT THE MIXTURE OF POLISHED AND ROUGH WAVY STRUCTURE AND THE NEW CIRCUMFERENTIAL LEDGE OBSERVED ON THE ANCHORING SIDE OF THE METASUL INSERT DERIVED FROM AUTOCLAVING. THESE CHANGES OCCURRED IN CONJUNCTION WITH THE FACT THAT THE INSERT WAS STILL IN THE SHELL DURING AUTOCLAVING AND ORGANIC DEPOSITS WERE PRESENT BETWEEN THE TWO COMPONENTS. THE WEAR MEASUREMENT DID NOT REVEAL AN ELEVATED WEAR VALUE FOR THE METASUL HEAD. FOR THE METASUL ALPHA INSERT A CLEAR WEAR ZONE COULD NOT BE IDENTIFIED BUT THE MEASURED DIAMETER IS STILL WITHIN THE MANUFACTURING TOLERANCES. SIGNS OF FRETTING CORROSION WERE OBSERVED ON THE HEAD TAPER SURFACE. THE CONDITIONS OF MOUNTING OF THE HEAD ON THE STEM TAPER E.G. IMPACTION FORCE, IMPACTION ANGLE, CONDITION OF THE TAPER SURFACES (DRY, WET) ARE FACTORS THAT INFLUENCE THE QUALITY OF THE TAPER CONNECTION. THE SMEARED LINES PERPENDICULAR TO THE RIM SEEN ON THE METASUL INLAY AND THE SLIGHT INDENTATIONS OBSERVED ON THE ARTICULATION SURFACE OF THE HEAD COULD POSSIBLY POINT TO A SUBLUXATION SITUATION. HOWEVER, AS THE COMPLETE X-RAY FOLLOW-UP AND/OR THE PATIENT¿S MEDICAL HISTORY ARE NOT AT HAND THE SITUATION STAYS UNKNOWN. THE REVISED CPT STEM WAS NOT AT HAND FOR EVALUATION. CLINICAL INFORMATION (E.G. X-RAY FOLLOW-UP, PATIENT¿S MEDICAL HISTORY, SURGICAL REPORTS OR HISTOLOGICAL EXAMINATION RESULTS) IS NOT AVAILABLE AND THEREFORE THE FURTHER BACKGROUND OF THIS CASE IS NOT KNOWN. BASED ON THE RETRIEVAL INVESTIGATION AND THE AVAILABLE INFORMATION THE REASON FOR THE PHENOMENA MENTIONED IN THE PER (COLLECTION OF FLUID AND PAIN, METALLOSIS, SUSPECTED TRUNIONOSIS) STAYS UNKNOWN. 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).

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: METASUL, ALPHA INSERT, II/32, (B)(4), LOT#: 2464429; ALLOFIT ALLOCLASSIC SHELL 52/I I, (B)(4), LOT#: 2472443. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00340. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E METASUL KOPF 28, 12/14, GRÖSSE S/-3.5, K091973) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(6) REFERENCE NUMBER (B)(4) (0002648920-2018-00171). ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE AND WAS SUBSEQUENTLY REVISED AFTER MORE THAN 9 YEARS DUE TO METALLOSIS, FLUID COLLECTION AND PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
172960	METASUL, HEAD, M, 32/0, TAPER 12/14	N/A	LZO	ZIMMER GMBH	N/A	2464451

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Hospitalization\| R