BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LH 130 DEG 11MM X 380MM

    MDR report key: 11127003 · Received January 6, 2021

    Report

    Report Number
    0001825034-2021-00014
    Event Type
    Injury
    Date Received
    January 6, 2021
    Date of Event
    December 17, 2020
    Report Date
    May 25, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K100238
    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

    VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE NAIL (PART 814611380) IS FRACTURED. ALL PIECES OF THE NAIL WERE RETURNED. DEVICE WERE SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED FOR THE FRACTURED NAIL (PART 814611380 LOT 059310, SEM 2103-022) CONFIRMED THE CM NAIL MATERIAL TO BE CONSISTENT WITH TI6-4 TITANIUM ALLOY. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS A MILDLY DISPLACED FRACTURE OF THE PROXIMAL FEMORAL INTRAMEDULLARY NAIL WITH VARUS ANGULATION AT THE PROXIMAL FEMORAL FRACTURE SITE, WHICH IS NOT UNITED. THE MORE PROXIMAL OF THE TWO DISTAL INTERLOCKING SCREWS IS ALSO FRACTURED. THERE IS ABNORMAL VARUS ALIGNMENT AT THE PROXIMAL FEMUR FRACTURE SITE. BONE QUALITY IS OSTEOPENIC. PATIENT ANATOMY APPEARS UNREMARKABLE AND NO CONTRIBUTING FACTORS ARE IDENTIFIED. THERE IS NO RADIOGRAPHIC EVIDENCE OF TRAUMA. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00015. CONCOMITANT MEDICAL PRODUCTS: DELANO LAG SCREW ITEM #: 814510105 LOT #: UG1111305D, DELANO A/R SCREW ITEM #: 814501090 LOT #: DNCCM1. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT REVISION APPROXIMATELY FOUR (4) MONTHS AGO POST IMPLANTATION DUE TO NON-UNION OF THE FRACTURE AND FRACTURING OF THE NAIL AND LAG SCREW. IT WAS REPORTED APPROXIMATELY THREE (3) WEEKS AGO PATIENT UNDERWENT REVISION. DURING PROCEDURE, COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21688 HFN LH 130 DEG 11MM X 380MM PROSTHESIS/TRAUMA HSB ZIMMER BIOMET, INC. N/A 059310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R