BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7057046 · Received November 23, 2017

    Report

    Report Number
    0009613350-2017-01620
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 31, 2017
    Report Date
    May 29, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PK100111
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ITEM: UNKNOWN NCB SCREWS CATALOG #: UNKNOWN LOT #: UNKNOWN. INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. CURRENTLY, ADDITIONAL INFORMATION IS NOT AVAILABLE. DHR-REVIEW: ITEM#: 02.02264.112 LOT#: 2851382 YIELD: 24 DELIVERED: 24 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 BREAKAGE EVENT DESCRIPTION: THE PATIENT HAD NCB PP FEMORAL PLATE IMPLANTED ON (B)(6), 2017 AND IT WAS REVISED TO ZNN ANTEGRADE FEMORAL NAIL ON (B)(6), 2017 AS THE PLATE FRACTURED INTO TWO PIECES. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: - THE CORRECT IMPLANTATION PROCEDURE OF THE PRODUCT IS DESCRIBED IN THE SURGICAL TECHNIQUE. - RAW MATERIAL CERTIFICATE CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: - BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING. POSSIBLE, NO PRODUCT WAS RETURNED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO INADEQUATE IMPLANT DESIGN & MATERIAL (FATIGUE 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, NO PRODUCT WAS RETURNED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO IMPLANT WILL BE IMPLANTED AGAINST CONTRAINDICATION. POSSIBLE, NO EVIDENCE TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION. POSSIBLE, NO X-RAYS RECEIVED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF THE IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS. POSSIBLE, NO X-RAYS RECEIVED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO TOO MANY BENDING CYCLES AT THE SAME SPOT OR USE OF NCB SCREW HOLES WHICH HAVE BEEN BENT. POSSIBLE, NO PRODUCT WAS RETURNED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE. POSSIBLE, IT IS UNKNOWN IF SPACERS WERE USED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION. POSSIBLE, NO EVIDENCE TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF THE IMPLANT DUE TO TOO MANY BENDING CYCLES AT THE SAME SPOT OR USE OF NCB SCREW HOLES WHICH HAVE BEEN BENT. POSSIBLE, NO PRODUCT WAS RETURNED, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION. POSSIBLE, NO EVIDENCE TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - BREAKAGE OF IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL. POSSIBLE, NO EVIDENCE TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. CONCLUSION SUMMARY: THE NCB PP PLATE BROKE APPROX. 2.5 MONTHS POST-OP. RAW MATERIAL CERTIFICATE CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. NEITHER PRODUCT NOR X-RAYS/SURGICAL REPORTS HAVE BEEN RECEIVED. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. POSSIBLE REASONS FOR THE REPORTED BREAKAGE CAN INCLUDE OVER STRESSING OF THE PLATE DURING THE IN VIVO TIME , MOVEMENT BETWEEN IMPLANTS LEADING TO NOTCHING / FRETTING, CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL, IMPLANT BEING IMPLANTED AGAINST CONTRAINDICATION, WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION, WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS, TOO MANY BENDING CYCLES AT THE SAME SPOT OR USE OF NCB SCREW HOLES, INCORRECT PLACEMENT OF THE SPACERS AND PLATE, IMPROPER HANDLING OF THE PLATE DURING INSERTION, WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION AND/OR WRONG PATIENT BEHAVIOUR. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) 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 FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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 WAS IMPLANTED A NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 12 HOLES, 278 MM ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835901 NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 12 HOLES, 278 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM HRS ZIMMER GMBH N/A 2851382

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R