BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, II/32

    MDR report key: 7340641 · Received March 15, 2018

    Report

    Report Number
    0009613350-2018-00358
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    January 16, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: METASUL, HEAD, L, 32/+4, TAPER 12/14, REF# (B)(4). , LOT#: 2241746 ALLOFIT ALLOCLASSIC SHELL 52/I I, REF# 4245, LOT#: 2250772 TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION SURGERY DUE TO OSTEOLYSIS. DHR-REVIEW: LOT #: 2248589 REF: (B)(4). YIELD: 20. DELIVERED: 20. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. LOT #: 2250772 REF: (B)(4). YIELD: 75. DELIVERED: 75. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. LOT #: 2241746 REF: (B)(4). YIELD: 60. DELIVERED: 60. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: THE ALLOFIT ALLOCLASSIC SHELL, METASUL ALPHA INSERT AND METASUL HEAD WERE REVISED AFTER MORE THAN 12 YEARS IN VIVO. OSTEOLYSIS WAS FOUND DURING THE IMAGE ASSESSMENT AT THE HOSPITAL WITHOUT SIGNS OF MOBILIZATION OF THE IMPLANT. REVIEW OF RECEIVED DATA: - REVIEW OF AVAILABLE INFORMATION. DOCUMENTS SUCH AS ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER), SURGICAL NOTES AND X-RAYS WERE NOT RECEIVED FOR INVESTIGATION. IT IS STATED THAT INTRAOPERATIVE PICTURES AND X-RAYS ARE NOT AVAILABLE DUE TO CONFIDENTIAL POLICIES. HOWEVER, A LETTER INCLUDING AN INCIDENT DESCRIPTION WRITTEN BY THE COMPLAINANT WAS RECEIVED IN FRENCH. THE AUTHOR OF THE REPORT IS NOT FAMILIAR WITH THE FRENCH LANGUAGE AND TO REVIEW THE CONTENT AN ONLINE TRANSLATION TOOL WAS USED. WHERE REQUIRED, A FRENCH SPEAKING PERSON WAS CONSULTED. THE CONTENT OF THE DOCUMENT IS SUMMARIZED BELOW. - LETTER BY THE SURGEON INCIDENT DESCRIPTION IN THE LETTER THE SURGEON INFORMS OF AN INCIDENT REGARDING THE RECEIVED DEVICES AND POINTS TO THE INCIDENT DESCRIPTION. - INCIDENT DESCRIPTION A 31-YEAR-OLD PATIENT, OPERATED IN 2005 ON A TOTAL RIGHT HIP PROSTHESIS FOR OSTEONECROSIS AFTER CORTISONE TREATMENT. OSTEOLYSIS WAS FOUND DURING THE IMAGE ASSESSMENT AT THE LEVEL OF THE GREATER TROCHANTER AND AT THE ROOF OF THE ACETABULUM EVOKING A REACTION TO THE POLYETHYLENE. NO SIGNS OF MOBILIZATION OF THE IMPLANT WERE OBSERVED. THE DECISION WAS TAKEN TO REVISE THE CUP AND PERFORM A GRAFT OF THE TROCHANTER REGION. THE INTRAOPERATIVE FINDING STATES MAJOR OSTEOLYSIS AT THE ROOF OF THE ACETABULUM AND OSTEOLYSIS OF THE GREATER TROCHANTER. THE ABSENCE OF METALLOSIS IS NOTED. ON THE POLYETHYLENE THERE ARE STRIPES DUE TO MICROMOTION BETWEEN SHELL AND POLYETHYLENE. AS CLINICAL CONSEQUENCE THE HEAD AND INSERT WERE CHANGED. DEVICES ANALYSIS: - VISUAL EXAMINATION UPON RECEIPT THE METASUL ALPHA 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. THERE ARE BONE ATTACHMENTS VISIBLE ON THE ANCHORING SIDE OF THE ALLOFIT ALLOCLASSIC SHELL. IN ONE AREA COURSE DAMAGE CAN BE OBSERVED WHICH MOST LIKELY OCCURRED DURING THE REVISION SURGERY. SOME OF THE DAMAGE EXTENDS OVER THE RIM TO THE INSIDE OF THE SHELL. THE LATTER EXHIBITS SEVERAL CONCENTRICALLY POLISHED STRIPES AND ONE OF THE ANTIROTATIONAL SPIKES IS MISSING. THE VERTICAL AREA OF THE SHELL'S SNAP FEATURE IS ALSO POLISHED. ON THE BOTTOM OF THE POLE PLUG AS WELL AS ON A SMALL STRIPE, NEXT TO THE HOLE OF THE MISSING ANTIROTATIONAL SPIKE, SOME WHITE RESIDUAL CAN BE OBSERVED. NEXT TO THE SIZE MARKING (52/II) SOME SLIGHT DAMAGE IS RECOGNIZABLE. THE BACKSIDE OF THE METASUL ALPHA INSERT EXHIBITS CONCENTRICALLY POLISHED AND WORN STRIPES MATCHING TO THE ONES OBSERVED ON THE INSIDE THE SHELL. IN BETWEEN THESE STRIPES THE MACHINING MARKS ARE OBLITERATED. THERE IS A NEWLY FORMED CIRCULAR GROOVE VISIBLE AT THE HEIGHT OF THE ANTIROTATIONAL SPIKES. THERE IS A PUNCTURE IN THE SPHERICAL AREA AND TWO ADDITIONAL PUNCTURES (CONNECTED WITH A SCRATCH) IN THE POLISHED CIRCLE AROUND THE PIN. BOTH OBSERVATIONS MOST LIKELY DERIVED FROM THE ANTIROTATIONAL SPIKES. THE POLE PIN IS SLIGHTLY DEFORMED AND SHOWS A NEWLY FORMED LEDGE. IN SOME AREAS OF THE PIN, THE MACHINING MARKS ARE STILL VISIBLE. THE RIM OF METASUL ALPHA INSERT SHOWS SOME COARSE REVISION DAMAGE IN THE FORM OF CUTINS AND PUNCTURES IN ONE AREA. THESE PROBABLY DERIVED DURING REVISION WHEN ATTEMPTS WERE MADE TO REMOVE THE INSERT OUT OF THE SHELL. AS A RESULT THE POLYETHYLENE WAS DEFORMED. THERE ARE SOME CRACKS NOTICEABLE IN THIS AREA OF THE RIM. IT IS UNKNOWN WHETHER THE CRACKS EXISTED ALREADY OR OCCURRED AS A CONCOMITANT OF THE DEFORMATION. THE CRACKS COULD INDICATE MATERIAL EMBRITTLEMENT DUE TO OXIDATION. THE INLAY IS LOOSE AND SUBSIDED TO ONE SIDE. IT CAN BE ROTATED AND SLIGHTLY TILTED WITHIN THE POLYETHYLENE LINER. WHEN TAPPING THE INSERT ON THE RIM IT IS POSSIBLE TO REMOVE THE INLAY OUT OF THE LINER. THE INSIDE OF THE LINER EXHIBITS A SLIGHTLY ROUGHED APPEARANCE IN SOME AREAS AND THE OUTSIDE OF THE INLAY SHOWS SLIGHTLY BRIGHTER CIRCULAR LINES ON THE STEPS. BOTH OBSERVATIONS MOST LIKELY DERIVED FROM THE RELATIVE MOVEMENT TO EACH OTHER. ON THE ARTICULATION SIDE OF THE INSERT NUMEROUS FINE SCRATCHES AND SLIGHT DAMAGES FROM AN ELECTROSURGICAL TOOL CAN BE SEEN ON THE INLAY. THE INSERT WAS CLOSER INVESTIGATED USING A LOW POWER MICROSCOPE, TYPE LEICA MZ16 A. IN ONE AREA ON THE ARTICULATION SURFACE SOME MICROPITS CAN BE OBSERVED. THE ROUND BEVEL HAS A SLIGHTLY ROUGHENED APPEARANCE AND CLOSE TO THE EDGE BETWEEN BEVEL AND ARTICULATION SURFACE SOME SHORT SCRATCHES CAN BE SEEN. THE ARTICULATION SURFACE OF THE METASUL HEAD SHOWS NUMEROUS FINE SCRATCHES AND A PARTIAL BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA UNDER CERTAIN LIGHT CONDITIONS. IN TWO AREAS CLOSE TO THE EQUATOR SEVERAL SPOTS AND LINES CAN BE OBSERVED MOST LIKELY DUE TO AN ELECTROSURGICAL TOOL. ON THE HEAD TAPER SURFACE CHANGES DUE TO FRETTING CORROSION WERE FOUND. THE ARTICULATION SURFACE OF THE METASUL HEAD WAS INSPECTED UNDER THE LIGHT MICROSCOPE 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. 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. - 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. ON THE WEAR MAP OF THE HEAD CREATED OUT OF THE MEASUREMENT DATA A CLEAR WEAR ZONE COULD BE IDENTIFIED WHICH CORRELATES WITH THE POSITION OF THE LOADED ZONE OBSERVED ON THE HEAD¿S ARTICULATION SURFACE. THE TOTAL, LINEAR WEAR VALUE IS 25.9 M WHICH RESULTS IN A YEARLY WEAR RATE OF 2.2 M. THE TIME IN VIVO WAS DEFINED TO BE 12 YEARS FOR THE DETERMINATION OF THE YEARLY WEAR RATE AS THE EXACT TIME IN VIVO IS NOT AVAILABLE. THE WEAR MAP OF THE INSERT SHOWS A POSSIBLE WEAR ZONE IN THE CENTER. HOWEVER, THE METHOD TO DETERMINE THE WEAR REQUIRES AN UNWORN AREA ON THE SAME PARALLEL OF MEASUREMENT POINTS. THEREFORE IT IS NOT POSSIBLE TO DETERMINE A WEAR VALUE. HOWEVER, THE MEASURED DIAMETER OF THE INSERT 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 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. CONCLUSION: THE ALLOFIT ALLOCLASSIC SHELL, METASUL ALPHA INSERT AND METASUL HEAD WERE REVISED AFTER MORE THAN 12 YEARS IN VIVO. OSTEOLYSIS WAS FOUND DURING THE IMAGE ASSESSMENT AT THE HOSPITAL WITHOUT SIGNS OF MOBILIZATION OF THE IMPLANT. THERE ARE NEITHER X-RAYS NOR SURGICAL REPORTS OF IMPLANTATION OR REVISION AVAILABLE FOR REVIEW. THE INTRAOPERATIVE FINDING STATES OSTEOLYSIS AT THE ROOF OF THE ACETABULUM AND THE GREATER TROCHANTER. THE ABSENCE OF METALLOSIS IS NOTED. NO SIGNS OF MOBILIZATION OF THE IMPLANT WERE REPORTED. THERE WERE NO SIGNS OF LOOSENING BUT BONE ATTACHMENTS OBSERVED ON THE ANCHORAGE SIDE OF THE SHELL. THEREFORE IT IS ASSUMED THAT THE SHELL WAS WELL ANCHORED IN THE ACETABULUM. THE CONCENTRICALLY POLISHED STRIPES OBSERVED ON THE BACKSIDE OF THE INSERT AND THE INSIDE OF THE SHELL INDICATE A RELATIVE MOVEMENT BETWEEN THE SHELL AND THE INSERT. AS A RESULT THE MACHINING MARKS BETWEEN THE STRIPES WERE OBLITERATED AND A CIRCULAR GROOVE WAS FORMED NEWLY ON THE BACKSIDE OF THE INSERT. IT IS ASSUMED THAT THE INSERT WAS ROTATING WITHIN THE SHELL. THE SHELL¿S SPIKES MOST LIKELY FORMED THE OBSERVED GROOVE AND DURING THESE MOVEMENTS. THE NEWLY FORMED LEDGE FOUND ON THE POLE PIN DERIVED PROBABLY DUE TO CONTACT WITH THE SHELL. FURTHER THE INLAY WAS LOOSE WITHIN THE POLYETHYLENE LINER AND IT WAS POSSIBLE TO REMOVE IT FROM THE LINER WHEN TAPPING THE INSERT ON THE RIM. ON THE RIM OF THE POLYETHYLENE LINER SOME CRACKS ARE PRESENT WHICH COULD INDICATE AN EMBRITTLEMENT OF THE MATERIAL DUE TO OXIDATION. WHETHER THIS COULD HAVE HAD AN INFLUENCE ON THE SEQUENCE OF EVENTS REMAINS UNKNOWN. THE REASON FOR THE LOOSE AND REMOVABLE INLAY AS WELL AS THE MISSING ANTIROTATIONAL SPIKE ON THE SHELL¿S INSIDE IS UNKNOWN. IT STAYS UNCLEAR AT WHAT POINT IN TIME THE SPIKE GOT SEPARATED FROM THE INSIDE OF THE SHELL. ON THE HEAD TAPER SURFACE CHANGES DUE TO FRETTING CORROSION WERE OBSERVED. BASED ON THE AVAILABLE DATA THE REASON FOR THESE SURFACE CHANGES CANNOT BE DETERMINED. THE APPEARANCE OF THE METASUL-PAIRING¿S ARTICULATION SURFACES DOES NOT INDICATE SIGNS OF ABNORMAL WEAR. THE WEAR VALUE OF THE HEAD IS SLIGHTLY ABOVE A THIRD OF THE ANNUAL AVERAGE WEAR RATE GIVEN IN. A WEAR VALUE FOR THE INSERT COULD NOT BE DETERMINED DUE TO THE LIMITATIONS OF THE ANALYSIS METHOD. HOWEVER, THE MEASURED DIAMETER OF THE INSERT IS STILL WITHIN THE MANUFACTURING TOLERANCES. ON THE BASIS OF RETRIEVAL INVESTIGATION IT CAN ONLY BE HYPOTHESIZED THAT THE POLYETHYLENE WEAR, ORIGINATING FROM THE RELATIVE MOVEMENT BETWEEN THE SHELL AND THE INSERT, COULD POSSIBLY HAVE CONTRIBUTED TO THE OSTEOLYSIS LEADING TO THE REVISION SURGERY. IT REMAINS UNKNOWN IF THE SURFACE CHANGES FOUND ON THE HEAD TAPER COULD BE AS WELL A CONTRIBUTING FACTOR TO THE OSTEOLYSIS. 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 PRODUCT: METASUL HEAD, L, 32/+4, TAPER 12/14, REF#19.32.07, LOT#2241746. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E .DURASUL ALPHA INSERT NEUTR II/32, K013935) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE METASUL INSERT, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A LOT NUMBER WAS RECEIVED FOR THE METASUL HEAD: 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A THA ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY 12 YEARS POST IMPLANTATION DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185387 METASUL, ALPHA INSERT, II/32 N/A KWA ZIMMER GMBH N/A 2248589

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R