BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PP DIS FEM PLT L9H L238MM

    MDR report key: 8173668 · Received December 18, 2018

    Report

    Report Number
    0009613350-2018-01263
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 27, 2018
    Report Date
    July 23, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024292888
    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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PLATE BREAKAGE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE AND UNDERWENT REVISION ON (B)(6) 2011 DUE TO IMPLANT AND FEMUR FRACTURE. REVIEW OF RECEIVED DATA: THERE ARE TWO PICTURES AVAILABLE. ON BOTH PICTURES IT CAN BE SEEN THAT THE NCB PP PLATE WAS BROKEN THROUGH A BORE HOLE OF A THREE HOLE PATTERN AND ALSO THE SMALL HOLE OF THE MIF INTERFACE. IN ADDITION TO THE PLATE, THERE ARE ALSO SCREWS, CABLES AND A HIP PROSTHESIS VISIBLE WITHOUT REF AND LOT NUMBER WHICH IS CONSIDERED A COMPETITOR PRODUCT. THE PICTURES WERE TAKEN RIGHT AFTER THE REVISION AS THERE ARE STILL BLOOD ON IT. NO PICTURES PROVIDED WHERE THE FRACTURE SURFACE IS VISIBLE. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION: IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE AND UNDERWENT REVISION ON (B)(6) 2018 DUE TO IMPLANT AND FEMUR FRACTURE. AS THE IMPLANT DATE IS NOT GIVEN THE IN VIVO TIME IS UNKNOWN. IT IS MENTIONED THAT THE NCB PP PLATE AND FEMUR WAS FRACTURED. THE PICTURES PROVIDED CONFIRM THE BREAKAGE OF THE NCB PP PLATE. THE BREAKAGE IS LOCATED THROUGH A BORE HOLE OF A THREE HOLE PATTERN AND ALSO THROUGH THE SMALL HOLE FOR THE MIF INTERFACE. AS NO X-RAYS HAVE BEEN RECEIVED, THE BONE FRACTURE CANNOT BE CONFIRMED. THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. . THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. NEITHER X-RAYS OR OPERATIVE NOTES WERE RECEIVED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. 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

    PLEASE REFER TO REPORT 0009613350 - 2018 - 01263.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO NCB PP PLATE AND FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015314 NCB PP DIS FEM PLT L9H L238MM NCB® PERIPROSTHETIC DISTAL FEMUR PLATE, STERILE, LEFT, 9 HOLES, L. 238 MM HRS ZIMMER GMBH N/A UNKNOWN 00889024292888

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R