BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7556189 · Received May 31, 2018

    Report

    Report Number
    0009613350-2018-00564
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 3, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PK042695
    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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURE. DHR-REVIEW: REF#: 02.03260.013, LOT#: 2926587. YIELD: 25. DELIVERED: 25. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: IT HAS BEEN REPORTED THAT A RIGHT FEMUR PLATE CONSISTING OF 13 HOLES FRACTURED UPON A FALL OF THE PATIENT. REVIEW OF RECEIVED DATA: FIVE X-RAYS HAVE BEEN RECEIVED (2X (B)(6) 2018, 2X (B)(6) 2018, 1X (B)(6) 2018). IN (B)(6) 2018: FEMUR RIGHT AP / LATERAL VIEW: VISIBLE INCLINED FRACTURE LINE FROM CRANIAL OF THE TIP OF THE HIP PROSTHESIS TO CAUDAL OF THE TIP OF THE HIP PROSTHESIS. THE CRANIAL FRAGMENT IS SHIFTED TO DORSAL BY THE WIDTH OF THE CORTICALIS. INTACT CERCLAGE BELOW THE TIP OF THE HIP PROSTHESIS, LATERAL POSITIONED PLATE ABOVE CERCLAGE. SCREW PLACEMENT AT THE HEIGHT OF THE PROXIMAL FRACTURE LINE, NO SCREW PLACEMENT ALONG THE FRACTURE LINE. IN (B)(6) 2018: FEMUR RIGHT AP / LATERAL VIEW: VISIBLE FEMUR FRACTURE OF THE LATERALLY POSITIONED NCB PLATE AT THE HEIGHT OF THE FOURTH SCREW HOLE WITHOUT INSERTED SCREW ABOVE THE INTACT CERCLAGE. FRACTURE OF THE PLATE FROM CRANIAL LATERAL TO CAUDAL MEDIAL. PROXIMAL PART OF THE PLATE IS ABOUT 10° VARUS TILTED TOWARDS DORSAL DIRECTION AND CAUDAL SHIFTED BY AROUND ONE SCREW HOLE. BOTH, THE PROXIMAL AND THE DISTAL, PARTS OF THE PLATE ARE FEMORAL FIXED WITH NO SIGNS OF LOOSENING. REFRACTURE OF THE FEMUR ALONG THE PREVIOUS FRACTURE LINE WITH THE POSITION OF THE FRACTURED PLATE ACCORDING TO THE DISLOCATION OF THE OSSEUOS FRAGMENTS. THE STEM OF THE TEP WITHOUT RADIOLOGICAL SIGNS OF LOOSENING. IN (B)(6) 2018 (DAY UNKNOWN): AP PELVIS VIEW: RIGHT PROXIMAL FEMUR PROSTHESIS (MUTARS). LEFT TEP WITH NO RADIOLOGICAL SIGNS OF LOOSENING OR IMPLANT MALFUNCTIONING. VISIBLE BLADDER CATHETER. THREE SURGICAL REPORTS HAVE BEEN RECEIVED ((B)(6)2018): IN (B)(6) 2018 IMPLANTATION OF ZIMMERBIOMET NCB PLATE 13 HOLES PATIENT FALL UPON WHICH EMERGENCY SURGERY OF THE PREVIOUSLY IMPLANTED PLATE. OPENING OF THE PREVIOUS INCISION. REMOVAL OF THE COMPLETE OSTEOSYNTHESIS MATERIAL. CERCLAGES REMAINED IN PLACE. REPOSITION OF THE FEMORAL FRACTURE WITH A DISTAL FEMUR PLATE (NCB 13 HOLE RIGHT). FIXATION DISTAL AND PROXIMAL IN COMBINATION USING X-RAY CONTROL. PROXIMAL ADDITIONAL FIXATION USING A CERCLAGE AROUND STEM AND PLATE. CONSEQUENTLY, RESTORATION OF A STABLE AND ORTHOGRADE POSITION. IN (B)(6) 2018 EXPLANTATION OF ZIMMERBIOMER NCB PLATE 13 HOLES REMOVAL OF THE PREVIOUSLY IMPLANTED NCB PLATE. MACROSCOPIC NO INDICATION OF AN INFECTION. IN (B)(6) 2018 IMPLANTATION OF A CEMENTED MUTARS FEMUR SYSTEM IMPLANTATION OF A MUTARS FEMUR SYSTEM. NO ADDITIONAL, RELEVANT INFORMATION AVAILABLE. DEVICES ANALYSIS: VISUAL EXAMINATION: THE BROKEN PLATE WAS RETURNED FOR INVESTIGATION WITHOUT SUB COMPONENTS LIKE SCREWS OR CERCLAGE WIRES. THE FRACTURE OCCURRED THROUGH THE MIDDLE OF THE FIFTH SCREW HOLE FROM THE PROXIMALE END. THE NON-BONE-FACING IMPLANT SURFACE SHOWS MULTIPLE SURFACE DEFECTS. THERE ARE SCRATCHES ALL ALONG THE IMPLANT. FURTHER, DARK MARKS CAN BE FOUND AROUND THE THREE SCREW HOLES NEXT TO THE FRACTURE SITE ON THE DISTAL AND THE PROXIMAL PART. THE BONE-FACING IMPLANT SURFACE SHOWS SURFACE DEFECTS AS WELL. HOWEVER, THE SURFACE DEFECTS MAINLY CONSIST OF DENTS AND DRILL MARKS OF THE SCREW HOLES. ON THE FRACTURE SURFACES, AREAS WITH BEACH MARKS ARE VISIBLE WHICH POINT TO A FATIGUE FRACTURE. THE FRACTURE ORIGINS ARE LOCATED AT THE BEGINNING OF THE CHAMFER ON THE NON-BONE-FACING SIDE. THE FRACTURE SURFACES ARE PARTIALLY POLISHED, WHICH CAN BE ATTRIBUTED TO THE CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. FUNCTIONAL TEST: NO FUNCTIONAL TEST WAS PERFORMED AS THE PLATE IS FRACTURED. REVIEW OF PRODUCT DOCUMENTATION: NO COMPATIBILITY CHECK CAN BE PERFORMED AS ONLY ONE PRODUCT HAS BEEN REPORTED. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING. POSSIBLE, AS THE X-RAYS SHOW THAT CERCLAGE WIRES WERE USED. BREAKAGE OF IMPLANT DUE TO INADEQUATE IMPLANT DESIGN & MATERIAL (FATIGUE STRENGTH - LIFETIME OF THE DEVICE). NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION OR IN THE CURRENT PMS PROCESS. AND ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION, THE MATERIAL HAS BEEN TESTED. BREAKAGE OF IMPLANT DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL. NOT POSSIBLE, AS THE INVESTIGATION DID NOT REVEAL ANY SIGNS OF CORROSION. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION. NOT POSSIBLE, AS NO ISSUE WAS DETECTED ON THE PROVIDED X-RAYS. BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS. NOT POSSIBLE, AS NO ISSUE WAS DETECTED ON THE PROVIDED X-RAYS. BREAKAGE OF IMPLANT DUE TO USER PERFORM INADEQUATE FORCE TO THE PLATE. POSSIBLE, AS AN INADEQUATE APPLICATION OF FORCE MAY LEAD TO A REDUCED MECHANICAL STRENGTH OF THE PLATE, WHICH INCREASES THE RISK OF A PLATE FRACTURE. BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE. NOT POSSIBLE, AS NO SPACERS WERE USED AND THE X-RAY EVALUATION DID NOT CONFIRM ANY MALPOSITION OF THE PLATE. BREAKAGE OF THE IMPLANT DUE TO USER PERFORMS INADEQUETE FORCES TO THE PLATE. POSSIBLE, AS AN INADEQUATE APPLICATION OF FORCE MAY LEAD TO A REDUCED MECHANICAL STRENGTH OF THE PLATE, WHICH INCREASES THE RISK OF A PLATE FRACTURE. BREAKAGE OF THE IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION. POSSIBLE, AS IT REMAINS UNKNOWN IF SOME OF THE DETECTED SURFACE DEFECTS HAVE BEEN INTRODUCED DURING IMPLANTATION. BREAKAGE OF THE PLATE, MIGRATION OF THE SCREW DUE TO USER CHOOSE A WRONG ANGULAR DIRECTION FOR THE SCREW. NOT POSSIBLE, AS THE X-RAY EVALUATION AND THE REVIEW OF THE SURGICAL REPORTS DID NOT REVEAL WRONG ANGULAR DIRECTIONS OF THE SCREWS. BREAKAGE OF THE IMPLANT DUE TO WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION. POSSIBLE, AS THE PATIENT FELL POST-SURGERY. BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL. POSSIBLE, AS THE PATIENT FELL POST-SURGERY. BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL. POSSIBLE, AS THE PATIENT FELL POST-SURGERY. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NCB PLATE ON (B)(6) 2018 ON THE RIGHT SIDE. THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO IMPLANT FRACTURE, AFTER 24 DAYS IN-VIVO. BASED ON THE RETURNED PRODUCT (NCB PLATE WITHOUT SCREWS OR CERCLAGES) AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE VISUAL EXAMINATION CONFIRMED THE FRACTURE OF THE NCB PLATE THROUGH THE MIDDLE OF THE 5TH SCREW HOLE, STARTING FROM THE PROXIMAL END. THE STRUCTURE OF THE FRACTURE SURFACES CONSISTS OF BEACH MARKS WHICH POINT TO A FATIGUE FRACTURE. THE FRACTURE ORIGINS ARE LOCATED AT THE BEGINNING OF THE CHAMFER ON THE NON-BONE-FACING SIDE. DUE TO THE FATIGUE FRACTURE IT CAN BE ASSUMED THAT AN OVERLOAD OF THE NCB PLATE IN-VIVO OCCURRED. HOWEVER, IT REMAINS UNKNOWN HOW THE FALL OF THE PATIENT INFLUENCED THE FRACTURE OF THE PLATE. IT IS POSSIBLE THAT THE FRACTURE OF THE PLATE STARTED BEFORE THE FALL OF THE PATIENT, WHICH TRIGGERED THE FINAL FRACTURE OF THE PLATE, OR THE FALL OF THE PATIENT DAMAGED THE PLATE LEADING TO A REDUCED MECHANICAL STRENGTH WHICH LED TO THE FRACTURE OF THE PLATE AFTER THE FALL. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT TIME OF PRODUCTION. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE PLATE FRACTURE. 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

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MAY 24, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH NCB, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM. SUBSEQUENTLY PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE OF THE PLATE APPROXIMATELY THREE WEEKS POST IMPLANTATION. IT WAS ALSO REPORTED THAT PLATE FRACTURED DUE TO FALL OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400980 NCB, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM NCB PLATING SYSTEM HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R