BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB, FEMUR PLATE, RIGHT, 9 HOLES, 246 MM

    MDR report key: 9160646 · Received October 7, 2019

    Report

    Report Number
    0009613350-2019-00592
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    September 20, 2019
    Report Date
    February 6, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024297371
    PMA / PMN Number
    K042695
    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. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. COMPLAINT HISTORY REVIEW: THIS COMPLAINT HISTORY REVIEW WAS CONDUCTED CONSIDERING A TIMEFRAME OF ONE YEAR PRIOR TO THE EVENT DATE AND THEREAFTER, EXCEPT FOR THE LOT SEARCH WHICH IS NOT SUBJECT TO A TIMEFRAME. COMPLAINT HISTORY REVIEW FOR ITEM NUMBER 02.03260.009: THE SEARCH IDENTIFIED A TOTAL OF 0 COMPLAINTS FOR THE SAME LOT 2905287. THE SEARCH IDENTIFIED A TOTAL OF 4 COMPLAINTS FOR THIS DEVICE, ALL OF THESE COMPLAINTS COVER THE SAME OR A SIMILAR ISSUE. PART SPECIFIC INVESTIGATION: NO ADDITIONAL SIMILAR INVESTIGATED EVENTS (PLATE BREAKAGE) WITHIN LAST 1 MONTH FOR ITEM NUMBER 02.03260.009 HAS BEEN FOUND. ONLY 2 ADDITIONAL SIMILAR INVESTIGATED EVENTS (PLATE BREAKAGE) WITHIN LAST 6 MONTHS FOR ITEM NUMBER 02.03260.009 HAVE BEEN FOUND. RESULT: ISSUE EVALUATION REQUEST IS NOT REQUIRED. LOT SPECIFIC INVESTIGATION: NO SIMILAR INVESTIGATED EVENTS (PLATE BREAKAGE) FOR THE SAME LOT NUMBER 2905287 HAVE BEEN FOUND. RESULT: ISSUE EVALUATION REQUEST IS NOT REQUIRED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE ON (B)(6) 2019 DUE TO NCB PLATE FRACTURE. THE IMPLANTATION WAS ON (B)(6) 2019. REVIEW OF RECEIVED DATA: SEVERAL X-RAYS WERE RECEIVED AND REVIEWED BY AN INDEPENDENT HEALTHCARE PROFESSIONAL. THE X-RAYS ARE DATED BETWEEN (B)(6) 2019 AND (B)(6) 2013. THE X-RAYS HAVE A POOR IMAGE QUALITY. ON THE X-RAY DATED (B)(6) 2019 THE FRACTURE OF THE PLATE CAN BE CONFIRMED. THE NON-HEALING (MENTIONED IN THE SURGICAL REPORT - NON UNION) OF THE FRACTURE CAN BE CONFIRMED RADIOLOGICALLY. A SURGERY REPORT OF IMPLANTATION DATED (B)(6) 2019 AND EXPLANTATION DATED (B)(6) 2019 WAS RECEIVED. NO ABNORMALITY DETECTED IN THE SURGICAL REPORT OF IMPLANTATION. THE SURGERY REPORT OF EXPLANTATION DESCRIBES A NCB PLATE FRACTURE AFTER APPROX. 7 MONTHS DUE TO NON UNION. DEVICES ANALYSIS VISUAL EXAMINATION: THE BROKEN NCB FEMUR PLATE WAS RETURNED FOR INVESTIGATION. NO SUB COMPONENTS HAVE BEEN RETURNED. THE FRACTURE OF THE PLATE IS LOCATED THROUGH THE NINTH SCREW HOLE (COUNTED FROM PROXIMAL). ON BOTH FRACTURE SURFACES, BEACH LINES 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. ON THE FRACTURE SURFACES THERE ARE SMALL POLISHED AREAS AND SOME SCRATCHES, MOST PROBABLY DUE TO CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. THERE ARE ALSO SEVERAL SCRATCHES VISIBLE ON THE SURFACE OF THE NON-BONE-FACING SIDE OF THE PLATE. REVIEW OF PRODUCT DOCUMENTATION THIS DEVICE IS INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT HAS BEEN REPORTED. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. RAW MATERIAL CERTIFICATE REVIEWED ON: 21-JAN-2020. CONCLUSION SUMMARY IT WAS REPORTED THAT A REVISION SURGERY WAS DONE ON (B)(6) 2019 DUE TO NCB PLATE FRACTURE. THE IMPLANTATION WAS ON (B)(6) 2019. THE PLATE WAS IN VIVO FOR APPROXIMATELY 7 MONTHS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) FOR THE NCB PLATE HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE VISUAL EXAMINATION OF THE PLATE INDICATES THAT NO MATERIAL DEFECTS THAT COULD HAVE TRIGGERED THE FRACTURE COULD BE DETECTED. THE MATERIAL ANALYSIS SHOWS AN INDICATION FOR A FATIGUE FRACTURE. THE SURGICAL REPORT OF IMPLANTATION DESCRIBES THAT THE NCB PLATE WAS BROKEN DUE TO NON UNION. THE NON-HEALING OF THE FRACTURE CAN BE ALSO CONFIRMED ON THE X-RAYS. 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 COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE NCB PLATE WAS BROKEN AFTER APPROX. 7 MONTHS DUE TO NON UNION. 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.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956572 NCB, FEMUR PLATE, RIGHT, 9 HOLES, 246 MM NCB PLATING SYSTEM HRS ZIMMER GMBH N/A 2905287 00889024297371

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R