BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9307662 · Received November 11, 2019

    Report

    Report Number
    1818910-2019-111739
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    May 16, 2016
    Report Date
    October 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "PRIMARY TOTAL HIP ARTHROPLASTY USING 3RD GENERATION CERAMIC-ON-CERAMIC ARTICULATION" WRITTEN BY BEOM H. SEO, DONG J. RYU, JOON S. KANG, AND KYOUNG H. MOON PUBLISHED BY HIP INTERNATIONAL HIP INT 2016; 00 (00): 000-000 DOI: 10.5301/HIPINT.5000375 PUBLISHED ONLINE 16 MAY 2016 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO EVALUATE CLINICAL AND RADIOGRAPHIC RESULTS AND COMPLICATIONS OF CEMENTLESS THA WITH 3RD GENERATION COC ARTICULATION. DATA WAS COMPILED FROM 310 THAS PERFORMED BETWEEN APRIL 2001 TO JANUARY 2008 WITH MEAN FOLLOW UP PERIOD OF 8.9 YEARS AND MEAN AGE AT INDEX SURGERY OF 54.6 YEARS OLD. DEPUY PRODUCTS UTILIZED: AML STEMS, DURALOC CUPS, COC BEARING SURFACES - ALL PRODUCTS IN ALL HIPS. THE ARTICLE REPORTS ON GENERALIZED ADVERSE EVENTS AND PROVIDES PATIENT IDENTIFIERS FOR TWO PATIENTS WITHIN NARRATIVE DESCRIPTION CAPTURED IN LINKED COMPLAINTS. THIS COMPLAINT CAPTURES A (B)(6) MAN WITH NO SIGNIFICANT TRAUMA WHO REPORTED LEFT HIP PAIN. IT WAS DISCOVERED THAT THE CERAMIC HEAD FRACTURED 15 MONTHS POST OPERATIVELY. HE RECEIVED REVISION AND NEW COC BEARING SURFACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097744 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention