BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TFN

    MDR report key: 14250476 · Received April 29, 2022

    Report

    Report Number
    2939274-2022-01540
    Event Type
    Injury
    Date Received
    April 29, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). LITERATURE CITATION: GOODNOUGH, L.H. ET AL. (2022), RISK OF REVISION AFTER HIP FRACTURE FIXATION USING DEPUY SYNTHES TROCHANTERIC FIXATION NAIL OR TROCHANTERIC FIXATION NAIL ADVANCED, THE JOURNAL OF BONE AND JOINT SURGERY, VOL. 00, PAGES 1-8 (USA) THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GOODNOUGH, L.H. ET AL. (2022), RISK OF REVISION AFTER HIP FRACTURE FIXATION USING DEPUY SYNTHES TROCHANTERIC FIXATION NAIL OR TROCHANTERIC FIXATION NAIL ADVANCED, THE JOURNAL OF BONE AND JOINT SURGERY, VOL. 00, PAGES 1-8 (USA). THE PRIMARY PURPOSE OF THIS STUDY WAS TO EVALUATE THE RISK OF REVISION RELATED TO THE INDEX FRACTURE FOLLOWING HIP FRACTURE REPAIR. USING THE TFNA COMPARED WITH THE TFN IN A LARGE U.S. INTEGRATED HEALTH-CARE SYSTEM. THE SECONDARY AIMS WERE TO CHARACTERIZE THE RISKS OF SPECIFIC REVISION REASONS BETWEEN THE TFN AND THE TFNA AND BETWEEN THE TFNA BLADE AND SCREW DESIGNS. THE STUDY SAMPLE COMPRISED PATIENTS WHO UNDERWENT CEPHALOMEDULLARY NAIL FIXATION FOR HIP FRACTURE WITH A TFN (N = 4,007) OR TFNA (N = 3,972) FROM 2014 TO 2019. THE MEDIAN AGE WAS 82 YEARS (IQR, 74, 88 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TFN/TFNA: 1,869 PATIENTS DIED AT A MEDIAN TIME OF 1.5 YEARS. TFN: REVISION REASON: (N=44) FIXATION FAILURE, (N=23) NONUNION, (N=8) FRACTURE, (N=1) INFECTION, (N=2) IMPLANT BREAKAGE (1 WAS DUE TO APERTURE FAILURES RELATED TO THE INDEX FRACTURE), (N=43) CUT-OUT. TFNA: REVISION REASON, (N=41) FIXATION FAILURE, (N=35) NONUNION, (N=8) FRACTURE, (N=2) INFECTION, (N=5) IMPLANT BREAKAGE (3 WERE DUE TO APERTURE FAILURES RELATED TO THE INDEX FRACTURE), (N=33) CUT-OUT. THIS REPORT IS FOR AN UNKNOWN SYNTHES TFN AND TFNA. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109535 UNK - CONSTRUCTS: TFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention