BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 10928358 · Received December 1, 2020

    Report

    Report Number
    1818910-2020-25817
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    August 31, 2019
    Report Date
    November 18, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    THE LITERATURE ARTICLE ENTITLED, "SUBSIDENCE AND PERIOPERATIVE PERIPROSTHETIC FRACTURES USING COLLARLESS HYDROXYAPATITE-COATED STEM FOR DISPLACED FEMORAL NECK FRACTURES ACCORDING TO DORR TYPE" WRITTEN BY JOO-HYOUN SONG, WOO-LAM JO, KEE-HAENG LEE, YOON-JOO CHO, JOONYOUNG PARK AND SEUNGBAE OH PUBLISHED BY JOURNAL OF ORTHOPAEDIC SURGERY ACCEPTED BY PUBLISHER 31 AUGUST 2019. THE ARTICLE'S PURPOSE WAS TO DETERMINE SUBSIDENCE RATE AND INCIDENCE OF PERIOPERATIVE PERIPROSTHETIC FRACTURE (PPF) OF UNCEMENTED COLLARLESS CORAIL STEMS FOR DISPLACED FEMORAL NECK FRACTURES ACCORDING TO DORR TYPE. DATA WAS COMPILED FROM 66 (DORR TYPE A), 107 (DORR TYPE B), AND 49 (DORR TYPE C) CASES. EARLY SUBSIDENCE IS NOTED IN 8 CASES BUT ALL WERE WELL FIXED WITHIN 2 YEARS. DEPUY PRODUCT: CORAIL STEM. ADVERSE EVENTS: POSTOPERATIVE FRACTURES (UNDETECTED INTRAOPERATIVELY AND TREATED WITH NON WEIGHT BEARING PROGRESSING TO PARTIAL WEIGHT BEARING) INTRAOPERATIVE FRACTURES (TREATED WITH WIRING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393123 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWY DEPUY FRANCE SAS - 3003895575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention