BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PF-VIRTEC SYSTEM CMTED LAT.6

    MDR report key: 8864868 · Received August 6, 2019

    Report

    Report Number
    0009613350-2019-00478
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 24, 2019
    Report Date
    April 1, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/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

    INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: THE PRODUCT WAS IMPLANTED ON JULY 01, 2004 AND REVISED ON JUL 24, 2019 DUE TO STEM FRACTURE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. PRODUCT EVALUATION: VISUAL EXAMINATION: THE PF STEM IS FRACTURED IN THE DISTAL NECK REGION. THE FRACTURE OCCURRED APPROXIMATELY 20 MM BELOW THE HEAD¿S BOTTOM, FEW MILLIMETERS ABOVE THE PROXIMAL EDGE OF THE IMPACTION HOLE. THE FRACTURE SURFACE OF THE PROXIMAL FRACTURE PART IS MOSTLY COARSELY SCRATCHED AND APPEARS POLISHED. THE FRACTURE SURFACE OF THE DISTAL FRACTURE PART SHOWS FEW SCRATCHES AND POLISHED AREAS. FEW BROWNISH SPOTS CAN ALSO BE RECOGNIZED ON THE DISTAL FRACTURE SURFACE. MACROSCOPICALLY, THE STILL INTACT FRACTURE STRUCTURE POINTS TO A FATIGUE FRACTURE. THE FATIGUE PORTION TAKES UP APPROXIMATELY TWO THIRDS OF THE TOTAL SURFACE. IN THE REMAINING ONE THIRD OF THE TOTAL SURFACE A RESIDUAL FRACTURE STRUCTURE IS PRESENT. THE FRACTURE STARTED FROM THE LATERAL SIDE OF THE STEM. IN THIS REGION, TWO ADJACENT FRACTURE PLANES ARE RECOGNIZABLE WHICH THEN COMBINE TO FORM A SINGLE PLANE. ON BOTH FRACTURE PARTS, THE EDGE OF THE FRACTURE SURFACE IS WORN AND EITHER DEFORMED OUTWARDS OR INWARDS. ON THE PROXIMAL FRACTURE PART, THE ENTIRE SURFACE OF THE STEM¿S NECK EXHIBITS A MIXTURE OF COARSE SCRATCHES, INSTRUMENT MARKS AND POLISHING. DUE TO THIS DAMAGE THE ORIGINAL SURFACE OF THE STEM IS NOT ANYMORE RECOGNIZABLE. ON THE DISTAL FRACTURE PART, THE STEM SHOULDER AND THE SURFACE ABOVE THE VERTICAL FINS SHOW VARIOUS DAMAGE IN THE FORM OF COARSE SCRATCHES, POLISHING, A BORE HOLE ON THE MEDIAL SIDE AND SEVERAL BROWNISH SPOTS. THE LATTER CAN ALSO BE OBSERVED CLOSE TO THE LATERAL EDGE OF THE FRACTURE SURFACE NEXT TO THE FRACTURE ORIGIN AREA. IT SEEMS THAT THE COARSE SCRATCHES AND POLISHING DAMAGE IS LOCATED ON TOP OF THE BROWNISH SPOTS. ON THE STEM¿S ANCHORING REGION, AREAS WITH AN ABRADED APPEARANCE CAN BE NOTICED ON THE PROXIMAL THIRD OF THE LATERAL SIDE, PROXIMAL HALF OF THE MEDIAL SIDE AS WELL AS ON/IN-BETWEEN THE VERTICAL FINS ON ONE SIDE OF THE STEM (ANTERIOR OR POSTERIOR, UNKNOWN IMPLANT POSITION). CLOSER INSPECTION OF THESE AREAS UNDER THE LOW-POWER MICROSCOPE TYPE LEICA MZ16 A SHOWED SMALL INDENTED MARKS. ON THE ENTIRE ANCHORING REGION OF THE STEM, AS WELL AS ON TOP OF THE ABOVE MENTIONED DAMAGE, FINE VERTICAL PARALLEL SCRATCHES CAN BE NOTICED. THEIR ORIGIN STAYS UNKNOWN. IN THE AS-RECEIVED CONDITION THE BIOLOX OPTION HEAD AND ADAPTER WERE STILL ASSEMBLED TO THE PROXIMAL FRACTURE PART OF THE PF STEM. FOR FURTHER INVESTIGATION AN ATTEMPT TO DISASSEMBLE THE PARTS WAS MADE. BEFORE, THE STEM TO ADAPTER POSITION WAS MARKED. IT WAS SUCCEEDED TO DISASSEMBLE THE HEAD FROM THE ADAPTER. AS THE ADAPTER WAS FIRMLY ATTACHED TO PROXIMAL FRACTURE PART OF THE STEM THE ATTEMPT TO REMOVE IT WAS STOPPED TO AVOID COARSER DAMAGE TO THE COMPONENTS. THE HEAD TAPER SHOWS THE COMMONLY OBSERVED MATERIAL TRANSFER FROM THE OUTER SURFACE OF THE ADAPTER. METALLIC SMEARING CAN BE NOTICED ON THE OUTER EDGE OF THE HEAD¿S BOTTOM. FURTHER, DIFFUSE METALLIC SMEARING CAN BE OBSERVED ON THE BOTTOM OF THE HEAD AND ON THE ARTICULATION SURFACE. EXCEPT FOR SOME DRIED DEPOSITS THE OUTER SURFACE OF THE HEAD ADAPTER IS INCONSPICUOUS. ON THE ARTICULATION SURFACE OF THE HEAD A ROUND GRAYISH-DISCOLORED REGION CAN BE RECOGNIZED IN THE POLE REGION. A MATT AREA WHICH EXTENDS OVER ONE SIDE OF THE HEAD UNTIL SLIGHTLY BELOW THE EQUATOR CAN BE RECOGNIZED NEXT TO THIS GRAYISH-DISCOLORED REGION. AROUND THE GRAYISH-DISCOLORED REGION THERE ARE SEVERAL SMALL WHITISH AREAS THAT HAVE A MATT APPEARANCE AS WELL. ALL THESE AREAS WERE FURTHER INSPECTED UNDER THE MICROSCOPE (NIKON EPIPHOT) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). COMPARED TO THE POLISHED HEAD SURFACE THE MATT AREA SHOWS HIGH DENSITY OF DARK APPEARING SPOTS. IN THE ROUND GRAYISH-DISCOLORED REGION SCATTERED DARK APPEARING SPOTS CAN BE RECOGNIZED. THE SMALL WHITISH AREAS HAVE PARTIALLY A CIRCULAR FORM AND SHOW A SIMILAR APPEARANCE AS THE MATT AREA. THE DARK APPEARING SPOTS COULD POSSIBLY BE PITS. IMPLANTATION VERSUS MANUFACTURING DATES: AFTER DISASSEMBLY OF THE HEAD FROM THE ADAPTER THE MARKING 05 / 1172 COULD BE OBSERVED ON THE HEAD. THIS MARKING POINTS TO THE FACT THAT THE HEAD WAS MANUFACTURED IN 2005 WHICH IS AFTER THE REPORTED IMPLANTATION DATE ((B)(6) 2004) OF THE STEM. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY THE COMPLAINED PRODUCT IS KNOWN. IT REMAINS UNKNOWN AT WHAT POINT IN TIME THE RECEIVED HEAD AND HEAD ADAPTER WERE IMPLANTED, AND WHICH DEVICES WERE IMPLANTED TOGETHER WITH THE STEM. DHR REVIEW: REVIEW OF THE MANUFACTURING DATA FOR LOT NO. 4001882 SHOWS THAT A TOTAL OF (B)(4) WERE ORDERED AND ALSO MANUFACTURED, WITHOUT A SCRAP DURING THE ENTIRE MANUFACTURING CYCLE. NCRS: THERE ARE NO NCR'S REGISTERED FOR LOT NUMBER 4001882. CONCLUSION: THE PF STEM WAS REVISED AFTER 15 YEARS AND 1 MONTH IN VIVO DUE TO A FRACTURE IN THE NECK REGION. THE FRACTURE OCCURRED DUE TO FATIGUE AND ORIGINATED FROM THE LATERAL SIDE OF THE STEM FEW MILLIMETERS ABOVE THE PROXIMAL EDGE OF THE IMPACTION HOLE. IN THIS REGION BROWNISH SPOTS AS WELL AS SEVERAL OTHER TYPES OF DAMAGE CAN BE RECOGNIZED CLOSE TO THE LATERAL EDGE OF THE FRACTURE SURFACE NEXT TO THE FRACTURE ORIGIN AREA. THE BROWNISH SPOTS MOST PROBABLY DERIVED FROM THE USE OF AN ELECTROSURGICAL INSTRUMENT DURING SURGERY. THE ABRADED AREAS CONSISTING OF SMALL INDENTED MARKS SEEN ON THE STEM¿S ANCHORING REGION AS WELL AS THE GRAYISH-DISCOLORED REGION AND MATT APPEARING AREAS ON THE ARTICULATION SURFACE OF THE HEAD POINT TO THIRD BODY WEAR. ACCORDING TO THE MARKING SEEN ON THE BIOLOX OPTION HEAD AFTER DISASSEMBLY (05 / 1172) THE PART WAS MANUFACTURED IN 2005. AS THE REPORTED IMPLANTATION DATE OF THE PF STEM IS (B)(6) 2004 IT CAN BE ASSUMED THAT A REVISION SURGERY WAS PERFORMED AT A LATER POINT IN TIME, POSSIBLY DUE TO A FRACTURE OF A CERAMIC COMPONENT. THUS, ANY CERAMIC PARTICLES THAT REMAINED IN SITU AFTER REVISION COULD HAVE LED TO THE PHENOMENA SEEN ON THE HEAD AND ANCHORING SURFACE OF THE STEM. CONSIDERING THE HYPOTHESIS THAT A REVISION WAS MADE AT A LATER POINT IN TIME ANY DAMAGE THAT MIGHT HAVE OCCURRED DURING THAT REVISION ON THE LATERAL SIDE OF THE STEM¿S NECK (E.G. SPOTS FROM ELECTROSURGERY, INSTRUMENT MARKS, ETC.) COULD HAVE BEEN A POSSIBLE CONTRIBUTING FACTOR TO THE FRACTURE. STUDIES PERFORMED ON TITANIUM ALLOY STEMS SHOWED THAT THE USE OF AN ELECTROSURGICAL INSTRUMENT DURING SURGERY CAN LEAD TO A SUPERFICIAL LOCAL DAMAGE AND A CHANGE IN MICROSTRUCTURE IN THE AFFECTED AREA WHICH CAN INCREASE THE RISK OF IMPLANT FRACTURE DUE TO REDUCED FATIGUE STRENGTH. AS THERE IS NO CLINICAL INFORMATION AVAILABLE (E.G. SURGICAL REPORTS, COMPLETE X-RAY FOLLOW-UP, PATIENT¿S MEDICAL HISTORY, ETC.) ANY INFLUENCING FACTORS THAT MAY RESULT FROM THESE ASPECTS REMAIN UNKNOWN. BASED ON THE RETRIEVAL INVESTIGATION AND THE RECEIVED INFORMATION, THE SEQUENCE OF EVENTS LEADING TO THE FATIGUE FRACTURE OF THE STEM AND ITS CAUSE STAY UNKNOWN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. 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 K040803. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY FIFTEEN YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657860 PF-VIRTEC SYSTEM CMTED LAT.6 N/A LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 4001882

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R