BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DWYER DISPLACEMENT TI-PLATE, SYS3.5, 6MM STEP

    MDR report key: 7478840 · Received May 2, 2018

    Report

    Report Number
    0009613350-2018-00470
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 3, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PK151407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: A4, H2, H4. CORRECTION: B4, D4, D10, G4, G7, H3, H6, H10. DEVICE HISTORY RECORDS (DHR): THE 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: IMPLANT FRACTURE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THAT AN OBESE PATIENT WAS IMPLANTED A DWYER PLATE AND A UNIVERSAL TI-PLATE ON (B)(6) 2017. IN THE WEEK FROM (B)(6) 2018 TO (B)(6) 2018 THE PATIENT CONTACTED THE DOCTOR BECAUSE OF PAIN IN THE OPERATED HEEL. EXAMINATION REVEALED A DORSALIZATION OF THE OSTEOTOMISED AND MEDIALIZED POSTERIOR CALCANEUS PORTION WITH PLATE FRACTURE. THE MEDIALIZATION HAD NOT BEEN AFFECTED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. FURTHER IT WAS DESCRIBED THAT THE DORSALIZATION AND PLATE FRACTURE WHILST THE MEDIALIZATION OF THE POSTERIOR CALCANEOUS COMPONENT HAS NOT BEEN AFFECTED, WOULD INDICATE THAT THE OBESE PATIENT HAS A) EITHER LOADED THE FOOT TOO EARLY B) OR HAS ACCIDENTIALLY STEPPED WITH FORCE ON THE HEEL. REVIEW OF RECEIVED DATA: CT SCANS: FOUR CT SCANS DATED (B)(6) 2018 HAVE BEEN RECEIVED. HOWEVER, DUE TO THE LOW QUALITY, NO ASSESSMENT COULD BE PERFORMED. SURGICAL REPORT: THE IMPLANTATION REPORT FROM (B)(6) 2017 HAS BEEN RECEIVED. DIAGNOSIS: ISOLATED, PAINFUL ARTHROSIS OF THE TALONAVICULAR AS WELL AS NAVICULOCUNEIFORM JOINT WITH FLEXIBLE FLATFOOT. PROCEDURE: A MEDIALIZING OSTEOTOMY OF THE CALCANEOUS AS WELL AS A TALONAVICULAR AND NAVICULOCUNEIFORM ARTHRODESIS HAVE BEEN PERFORMED. OSTEOTOMY OF THE CALCANEOUS OF 0.6MM TOWARDS MEDIAL USING "STEP PLATE" UND "ANGLE STABLE" SCREWS. OSTEOTOMY WAS FOUND TO BE CORRECT AND STABLE. AS A NEXT STEP THE ARTHODESIS IS PERFORMED. THE REPOSITIONING RESULT IS FIXED WITH A SMALL MEDIALIS-PLATE AND 6 "ANGLE STABLE" SCREWS (ZIMMER) USING INTROPERATIVE X-RAYS. ARTHRODESIS IS PUT UNDER PRESSURE. THE PATIENT HAS BEEN ADVISED TO WEAR AN ORTHOPEADIC WALKING BOOT DURING THE DAY FOR 6 WEEKS AND CAN LOAD THE LEG DEPENDING ON THE PAIN USING CRUTCHES. RADIOLOGICAL REPORT: ONE REPORT FROM A CT EXAMINATION ON (B)(6) 2018 HAS BEEN RECEIVED. IT IS MENTIONED THAT THERE HAS BEEN NO CORRECT FUSION OF THE CALCANEOUS AFTER THE OSTEOTOMY. NO COMPLETE SCLEROSIS AT THE OSTEOTOMY GAP. THE IMPLANTS WOULD SHOW NO SIGNS OF LOOSENING. THE ARTHODESIS BETWEEN TALUS AND NAVICULAR WOULD BE CORRECT IN REGARDS TO THE IMPLANTS. PATIENT WOULD INDICATE TO HAVE SWELLING AND PAIN. MOREOVER, INACTIVITY-OSTEOPOROSIS HAS BEEN DIAGNOSED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE DWYER PLATE AS WELL AS FIVE SCREWS HAVE BEEN RETURNED FOR AN INVESTIGATION. THE PLATE HAS FRACTURED. THERE ARE ALSO SOME SCRATCHES VISIBLE, WHICH HAVE MOST LIKELY BEEN CAUSED DURING THE REMOVAL OF THE PLATE. THE DISCOLORATIONS MIGHT HAVE RESULTED FROM THE CLEANING PROCESS AFTER REMOVAL OF THE PLATE. THE FRACTURE SURFACE HAS BEEN EXAMINED USING THE MICROSCOPE. IT SEEMS TO SHOW A FATIGUE FRACTURE. IT APPEARS THAT THE FRACTURE PROGRESSED FROM THE TOP END TO THE BOTTOM END. THE EXACT FRACTURE ORIGIN(S) CANNOT BE DETERMINED. MOREOVER, SEVERAL POLISHED AREAS CAN BE OBSERVED ON BOTH FRACTURE SURFACES, PROBABLY DUE TO CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE WERE FOUND ON THE FRACTURE SURFACES. REVIEW OF PRODUCT DOCUMENTATION. PRODUCT DRAWING: THE PRODUCT DRAWING HAS BEEN REVIEWED. THE DIMENSIONS MARKED WITH A CIRCLE ARE THE ONES WHICH HAVE BEEN INSPECTED. THE DEVICE HISTORY RECORDS (DHR) CONFIRMS THAT THE DIMENSIONS FROM 5 OF THE 7 MANUFACTURED PIECES HAVE BEEN INSPECTED AND IT WAS CONFIRMED THAT THEY MET THE SPECIFICATIONS. ROOT CAUSE ANALYSIS. ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF IMPLANT DUE TO LACK OF ADEQUATE STRENGTH NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT LOOSENING, NON-UNION DUE TO INSUFFICIENT STABILITY OF PLATE-SCREW COMPLEX NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. BREAKAGE OF IMPLANT DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. PROMINENT HARDWARE (PLATE AND SCREW) LEADING TO SOFT TISSUE IRRITATION DUE TO INADEQUATE DESIGN NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. BREAKAGE OF IMPLANT DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY POSSIBLE, AS IT IS UNKNOWN WHETHER THE DEVICE HAS BEEN REUSED. FAILURE OF SURGERY DUE TO MISINTERPRETATION OF INDICATIONS / CONTRAINDICATIONS AND FURTHER INSTRUCTION FOR USE POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. FAILURE OF SURGERY DUE TO WRONG SELECTION OF COMPONENTS OR USE IN COMBINATION WITH DEVICE OUTSIDE THE SYSTEM POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT REMAINS UNKNOWN WHETHER THE IMPLANT IS SUITABLE FOR THE OBESE PATIENT. DUE TO THE ABSENCE OF X-RAYS, IT CANNOT BE DETERMINED WHETHER THE RIGHT SIZE OF IMPLANT HAS BEEN CHOSEN. IMPLANT IS NOT ABLE TO PROVIDE ADEQUATE SUPPORT HEALING DUE TO WRONG DIMENSION OF PLATE . POSSIBLE, DUE TO THE ABSENCE OF X-RAYS, IT CANNOT BE DETERMINED WHETHER THE RIGHT SIZE OF IMPLANT HAS BEEN CHOSEN. FAILURE OF SURGERY DUE TO INSUFFICIENT WARNING OF SIDE EFFECTS POSSIBLE, AS IT REMAINS UNKNOWN WHETHER THE PATIENT HAS RECEIVED THE WARNINGS CONCERNING SIDE EFFECTS. CONCLUSION SUMMARY . IT WAS REPORTED THAT THAT AN OBESE PATIENT WAS IMPLANTED A DWYER PLATE ON (B)(6) 2017 AND WAS REVISED ON (B)(6) 2018 DUE TO PLATE FRACTURE. IT WAS SUSPECTED THAT THE PATIENT MIGHT HAVE DONE TOO EARLY WEIGHT BEARING OR HAS ACCIDENTIALLY PUT HIGH LOAD ON THE HEEL. THE ANALYSIS OF THE FRACTURE SURFACE SHOWED THAT IT RESEMBLES MOST LIKELY A FATIGUE FRACTURE. THE RADIOLOGICAL REPORT CONFIRMED A NON-UNION OF THE OSTEOTOMY. THIS COULD HAVE LED TO THE FORCES BEING SHIFTED TO THE PLATE AND THEREFORE AN OVERLOADING OF THE PLATE. MOREOVER, THE PATIENT HAS BEEN DIAGNOSED WITH INACTIVITY-OSTEOPOROSIS. THERE ARE SEVERAL FURTHER FACTORS WHICH COULD HAVE LED TO FRACTURE OF THE PLATE. THE REPORTED OVERWEIGHT OF THE PATIENT, THE IMPLANT POSITION AS WELL AS A NON-COMPLIANCE OF THE PATIENT TO THE REHABILITATION PROTOCOL COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REVIEW OF THE DHR INDICATES THAT THE HEAD MET ALL REQUIREMENTS TO PERFORM AS INTENDED. HOWEVER, BASED ON THE AVAILABLE INFORMATION AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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: RECON WDG P2 15X15X6, ITEM# 110003827, LOT# 096690, THERAPY DATE: (B)(6) 2018. MINICAN TI-SCREW, CANNULATED, PARTIAL THREAD, HEX, 3.5X32MM, ITEM# 28.22.032, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-SCREW, STANDARD, SYS3.5, HEX, 28MM, ITEM# 28.20.128, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 35MM, ITEM# 28.20.035, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 28MM, ITEM# 28.20.028, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 26MM, ITEM# 28.20.026, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018 UNIVERSAL TI-PLATE, H-SHAPE, SYS3.5, 22MM, ITEM# 28.01.522, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 30MM, ITEM# 28.20.030, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 28MM, ITEM# 28.20.028, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. UNIVERSAL TI-PLATE, H-SHAPE, SYS3.5, 16MM, ITEM# 28.01.516, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. TI-LOCKING SCREW, SYS3.5, HEX, 16MM, ITEM# 28.20.016, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018 TI-LOCKING SCREW, SYS3.5, HEX, 14MM, ITEM# 28.20.014, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. PRODUCT UNKNOWN, ITEM# 282024, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. PRODUCT UNKNOWN, ITEM# 282026, LOT# UNKNOWN, THERAPY DATE: (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. SURGICAL REPORT WAS RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY 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
    322025 DWYER DISPLACEMENT TI-PLATE, SYS3.5, 6MM STEP RECON SYSTEM HRS ZIMMER GMBH N/A 9436/291C11

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R