BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM

    MDR report key: 10383449 · Received August 10, 2020

    Report

    Report Number
    0009613350-2020-00367
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    April 28, 2019
    Report Date
    January 12, 2021
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024292840
    PMA / PMN Number
    K100111
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN NCB PROSTHETIC FEMUR PLATE AND CERCLAGE ON (B)(6) 2018 TO TREAT AN OBLIQUE FRACTURE DUE TO A FALL. ON (B)(6) 2019 SHE FELT A STRONG PAIN AND A BONE FRACTURE AND DISCONTINUITY OF THE PLATE WAS DIAGNOSED. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 DUE TO THE FRACTURE OF NCB PROSTHETIC FEMUR PLATE. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: THE X-RAY REVIEW WAS DONE BY A RADIOLOGIST. NEWLY INITIAL POSTOPERATIVE IMAGE DEMONSTRATES NORMAL POSITIONING OF LATERAL METALLIC SIDEPLATE IN THE MID TO DISTAL FEMUR WITH MULTIPLE INTACT CORTICAL SCREWS AND PRESENCE OF A CERCLAGE WIRES. THE HARDWARE AND BONE APPEAR WITHIN NORMAL LIMITS FOR THE POSTOPERATIVE STATE. SEVERAL MONTHS LATER, ON (B)(6) 2019 THERE IS A FRACTURE IN THE MIDPORTION OF THE METALLIC PLATE IN WHICH THE DISTAL PORTION OF THE PLATE IS MINIMALLY DISPLACED LATERALLY, RESULTING MILD TO MODERATE APEX LATERAL ANGULATION OF PLATE. METALLIC SCREWS APPEAR INTACT AND THE CERCLAGE WIRES APPEAR NORMAL. THE UNDERLYING BONE ALSO DEMONSTRATES AN ACUTE TO SUBACUTE FRACTURE WITH LUCENCIES PRESENT IN THE DISTAL FEMORAL DIAPHYSIS EXTENDING TO THE SUPRACONDYLAR PORTION OF THE FEMUR. THERE IS SOME CALLUS DEVELOPMENT ALONG THE MEDIAL MARGIN OF THE EPICENTER OF FRACTURE BONE/HARDWARE WHICH MAY REPRESENT REACTIVE BONE CHANGES TO RECENT FRACTURE (ASSUMING SUBACUTE NATURE). THE FEMUR ITSELF DEMONSTRATES VARUS ANGULATION AT THE SAME LOCATION OF THE HARDWARE FRACTURE. - SURGICAL REPORT: THE SURGICAL REPORTS IN ITALIAN LANGUAGE HAVE BEEN REVIEWED. THERE ARE LOT OF MEDICAL DATA OF THE PATIENT AND DATA FROM THE HOSPITALISATION AVAILABLE. HOWEVER NO CONSPICUOUS FINDINGS RELEVANT TO THE REPORTED EVENT COULD BEEN IDENTIFIED. PRODUCT EVALUATION: IT HAS BEEN REPORTED THAT THE PRODUCT IS NO LONGER AVAILABLE. NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET ACCORDING TO SURGICAL TECHNIQUE. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RAW MATERIAL CERTIFICATE: THE RAW MATERIAL CERTIFICATE WAS REVIEWED WITH NO ANOMALIES NOTED. REVIEW COMPLAINT HISTORY: A COMPLAINT HISTORY SEARCH FOR THE REFERENCE 02.02264.012 AND LOT 2947659 WAS DONE. NO OTHER COMPLAINTS FOUND WITH THE SAME REFERENCE AND LOT COMBINATION. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN NCB PROSTHETIC FEMUR PLATE AND CERCLAGE ON (B)(6) 2018 TO TREAT AN OBLIQUE FRACTURE DUE TO A FALL. ON (B)(6) 2019 SHE FELT A STRONG PAIN AND A BONE FRACTURE AND DISCONTINUITY OF THE PLATE WAS DIAGNOSED AND UNDERWENT REVISION SURGERY ON MAY 08, 2019 DUE TO THE FRACTURE OF NCB PROSTHETIC FEMUR PLATE. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) FOR THE NCB PP PLATE HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE RAW MATERIAL CERTIFICATE OF THE PLATE WAS REVIEWED WITH NO ANOMALIES NOTED. THEREFORE, THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE COMPLAINT HISTORY SEARCH IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE SAME REFERENCE AND LOT NUMBER COMBINATION. THE RECEIVED X-RAYS CONFIRM THE BREAKAGE OF THE NCB PP PLATE. FRACTURE OF THE BONE AND NCB PP PLATE DEMONSTRATED SEVERAL MONTHS AFTER HARDWARE PLACEMENT. AS THE PRODUCT WAS NOT RETURNED, THE NATURE OF THE FRACTURE COULD NOT BE FURTHER INVESTIGATED. ONE POSSIBILITY COULD BE THAT THE PLATE BROKE DUE TO FATIGUE. FATIGUE FRACTURES CAN OCCUR DUE TO A CYCLIC OVERLOADING. POSSIBLE CONTRIBUTING FACTORS TO THE OVERLOAD COULD BE A NOT PROPERLY HEALED BONE FRACTURE AND / OR NOT ADHERENCE TO THE POSTOPERATIVE PROTOCOL (PATIENT BEHAVIOR). IF AND TO WHAT EXTEND OTHER FACTORS MAY HAVE PLAYED A ROLE IN THE SEQUENCE OF EVENTS LEADING TO THE FRACTURE REMAINS UNKNOWN. BASED ON THE AVAILABLE INFORMATION AND PERFORMED INVESTIGATION, AN EXACT ROOT CAUSE FOR THE PLATE BREAKAGE AFTER SIX MONTHS IN VIVO 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).

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT NCB, CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE, 2.5 MM HEX DRIVE; CATALOG NO#: 47-2232-060-01; LOT#: 4502238816; NCB, CABLE BUTTON FOR NCB POLYAXIAL LOCKING PLATE, 2.5 MM HEX DRIVE; CATALOG NO#: 47-2232-060-01; LOT# 2948494; CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; CATALOG NO#: 00-2232-004-18; LOT# 64013672; CERCLAGE CABLE WITH CRIMP 1.8 MM DIAMETER CABLE 36 INCH (910 MM) LENGTH; CATALOG NO#: 00-2232-002-28; LOT# 63950650. THERAPY DATE: (B)(6) 2019. THE MANUFACTURER DID RECEIVE LEGAL DOCUMENTS AND SURGICAL REPORTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851399 NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM HRS ZIMMER GMBH N/A 2947659 00889024292840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R