BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

    MDR report key: 7586286 · Received June 11, 2018

    Report

    Report Number
    0009613350-2018-00599
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    June 28, 2017
    Report Date
    November 13, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PLATE BREAKAGE. EVENT SUMMARY: PATIENT WAS IMPLANTED WITH NCB PLATE ON UNKNOWN DATE AND WAS REVISED ON UNKNOWN DATE DUE TO BREAKAGE. PATIENT IS OBESE MORE THAN 100 KG, WITH CLINICAL KNEE ANKYLOSES AND AGGRESSIVE REHABILITATION EXERCISES. REVISION WAS PERFORMED WITH RETROGRADE IM NAIL AND PLATE WAS EXPLANTED. REVIEW OF RECEIVED DATA SEVERAL X-RAYS WERE RECEIVED. ALL X-RAYS WERE UNDATED. PELVIS OVERVIEW: COXARTHROSIS RIGHT, ADVANCED PROTRUSION ARTHROSIS LEFT. RIGHT FEMUR WITH KNEE JOINT AND TIBIAL PLATEAU AP/LATERAL-VIEW, RIGHT HIP WITH FEMUR AXILLARY. DISLOCATED, DISTAL FEMORAL STEM SPIRAL FRACTURE ON THE RIGHT, RECOGNIZABLE BRANCH OF THE FRACTURE TO SUPRACONDYLAR. CONDITION AFTER PLATE OSTEOSYNTHESIS OF TIBIAL PLATEAU MEDIAL AND LATERAL. RIGHT FEMUR WITH KNEE JOINT AP-VIEW, RIGHT HIP WITH FEMUR AP-VIEW, RIGHT KNEE JOINT OBLIQUE PROJECTION, RIGHT FEMUR OBLIQUE PROJECTION: CONDITION AFTER PLATE-OSTEOSYNTHESIS OF A DISTAL FEMORAL STEM SPIRAL FRACTURE WITH MEDIAL FLEXION WEDGE, THE FRACTURE IS NOT COMPLETELY REDUCED, SIGNIFICANT GAP BETWEEN THE PROXIMAL AND DISTAL FRAGMENT. RECOGNIZABLE DRILL HOLES IN THE HERE MARKED BONE FRAGMENTS AT THE LEVEL OF THE SECOND PLATE HOLE ABOVE THE SUPRACONDYLAR PLACED, SINGLE SCREW. IN THE AREA OF THE PROXIMAL BONE FRAGMENT AT THE LEVEL OF THE UPPER PLATE BEARING SEVERAL, FORMERLY OCCUPIED SCREW HOLES VISIBLE. DISTAL THE PLATE IS FIXED WITH 2 SCREWS THROUGH THE CONDYLES. IN THE AREA OF THE FRACTURE ZONE NO DIRECT CONTACT BETWEEN OSTEOSYNTHESIS PLATE AND BONE. NO EVIDENCE OF LOOSENING OF THE SCREW MATERIAL. RIGHT FEMUR WITH KNEE JOINT AP-VIEW: FRACTURE OF THE OSTEOSYNTHESIS PLATE AT THE LEVEL OF THE 2ND SCREW HOLE ABOVE THE SUPRACONDYLAR INDIVIDUALLY FIXED SCREW. THE EDGES OF THE BONY BENDING WEDGE ARE SCLEROSED, DISCREET PERIOSTEAL CALLUS FORMATION ON THE MEDIAL BORDER. VISIBLE RADIOLUCENCY AROUND THE TIP OF THE SUPRACONDYLAR SINGLE NARROW IN THE BENDING WEDGES FIXED SCREW. PELVIS OVERVIEW WITH RIGHT FEMUR: NO DETECTABLE ABNORMALITIES. RIGHT HIP WITH FEMUR AP/LATERAL-VIEW, RIGHT FEMUR WITH KNEE JOINT AND PROXIMAL TIBIA AP/LATERAL-VIEW, RIGHT FEMUR WITH KNEE JOINT LATERAL-VIEW: CONDITION AFTER RETROGRADE INTRAMEDULLARY NAILING WITH PROXIMAL AND DISTAL LOCKING. BONY DEFECT ZONE MEDIAL IN THE AREA OF THE FORMER BENDING WEDGE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING 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 IMPLANT DESIGN & MATERIAL (FATIQUE STRENGTH - LIFETIME OF THE DEVICE) 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 CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL. POSSIBLE, THE PLATE WAS NOT RETURNED FOR MATERIAL ANALYSIS, THEREFORE THIS POINT CANNOT BE EXCLUDED. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION NOT POSSIBLE. THE X-RAYS DO NOT SHOW ANY ABNORMALITY. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS NOT POSSIBLE. THE X-RAYS DO NOT SHOW ANY ABNORMALITY. BREAKAGE OF IMPLANT DUE TO USER PERFORM INADEQUATE FORCE TO THE PLATE. POSSIBLE, IT CAN BE CASE THAT THE USER PERFORMED INADEQUATE FORCE TO THE PLATE DURING THE IMPLANTATION. BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE NOT POSSIBLE. THE X-RAYS DO NOT SHOW ANY ABNORMALITY. BREAKAGE OF THE IMPLANT DUE TO USER PERFORMES INADEQUETE FORCES TO THE PLATE POSSIBLE, IT CAN BE CASE THAT THE USER PERFORMED INADEQUATE FORCE TO THE PLATE DURING THE IMPLANTATION. BREAKAGE OF THE IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION POSSIBLE, IT CAN BE CASE THAT THE USER PERFORMED IMPROPER HANDLING OF THE PLATE DURING THE IMPLANTATION. BREAKAGE OF THE IMPLANT DUE TO USER READ/INTERPRETS WRONG SCREW DEPTH NOT POSSIBLE THE X-RAYS DO NOT SHOW ANY ABNORMALITY. BREAKAGE OF THE IMPLANT DUE TO USER READ/INTERPRETS WRONG SCREW DEPTH NOT POSSIBLE THE X-RAYS DO NOT SHOW ANY ABNORMALITY. BREAKAGE OF THE IMPLANT DUE TO WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION POSSIBLE, THE INFORMATION ABOUT LIMITATION IS UNKNOWN. BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL POSSIBLE, IT CAN BE THAT THE PLATE WAS OVER STRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOUR CAN ALSO BE THE CAUSE FOR THE BREAKAGE. BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL POSSIBLE, IT CAN BE THAT THE PLATE WAS OVER STRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOUR CAN ALSO BE THE CAUSE FOR THE BREAKAGE. CONCLUSION SUMMARY AFTER PLATE OSTEOSYNTHESIS OF A DISLOCATED DISTAL FEMORAL STEM SPIRAL FRACTURE ON THE RIGHT, A PSEUDARTHROSIS IN THE FRACTURE AREA HAS DEVELOPED. THE EVENT DESCRIPTION DESCRIBES THAT THE PATIENT IS OBESE AND MORE THAN 100 KG. THE PLATE ITSELF HAS NOT BEEN RETURNED FOR FRACTURE ANALYSIS. THEREFORE, THE CONDITION OF THE PLATE IS UNKNOWN. THERE ARE SEVERAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. IT CAN BE THAT THE PLATE WAS OVER STRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOUR CAN ALSO BE THE CAUSE FOR THE BREAKAGE. HOWEVER, 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

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K042695. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2018 TO THE APPROPRIATE REPRESENTATIVES. 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 A PATIENT WAS IMPLANTED WITH NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM ON UNKNOWN DATE AND WAS REVISED ON UNKNOWN DATE DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431146 NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM N/A HRS ZIMMER GMBH N/A 2865240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R