BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9297097 · Received November 8, 2019

    Report

    Report Number
    1818910-2019-111732
    Event Type
    Injury
    Date Received
    November 8, 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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 THE GENERALIZED ADVERSE EVENTS: DISLOCATION TREATED WITH REVISION (CUP POSITION CHANGE AND NEW COC BEARING CHANGE) OR BY OPEN REDUCTION, SQUEAKING SOUND (NO INTERVENTIONS), HETEROTOPIC OSSIFICATION (NO INTERVENTIONS AND NO FUNCTIONAL IMPACT), INFECTION (TREATED WITH 2 STAGE EXCHANGE OF IMPLANT AND/OR SURGICAL DEBRIDEMENT), PERIPROSTHETIC FEMORAL FRACTURE (TREATED WITH ORIF WITH CERCLAGE CABLE AND PLATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093350 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention