BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9417808 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-120911
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    October 12, 2009
    Report Date
    November 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED, ¿INDIVIDUAL SUSCEPTIBILITY TO PERIPROSTHETIC OSTEOLYSIS IS ASSOCIATED WITH ALTERED PATTERNS OF INNATE IMMUNE GENE EXPRESSION IN RESPONSE TO PRO-INFLAMMATORY STIMULI¿ BY ANDREW GORDON, ET AL, PUBLISHED BY JOURNAL OF ORTHOPAEDIC RESEARCH (2010), PP. 1127-1135, DOI 10.1002/JOR.21135, WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EXAMINE WHETHER INDIVIDUALS WITH A SUSCEPTIBILITY TO OSTEOLYSIS AFTER THA HAVE QUANTITATIVELY DIFFERENT INNATE IMMUNE RESPONSES TO PRO-INFLAMMATORY STIMULI VERSUS INDIVIDUALS WHO DO NOT DISPLAY THIS SUSCEPTIBILITY. ALL PATIENTS IN THE STUDY GROUP WERE REVISED FOR OSTEOLYSIS AND IMPLANT LOOSENING BETWEEN MARCH AND NOVEMBER 2005. IMPLANTED DEPUY PRODUCTS: CHARNLEY THA CEMENTED WITH COMPETITOR CEMENT- POLYETHYLENE HEAD, 22-MM FEMORAL HEAD, AND FEMORAL STEM. RESULTS: THERE WERE NO REVISIONS OR COMPLICATIONS OF THE REVISED PROSTHESES. THIS COMPLAINT CAPTURES THE CHARNLEY THA INDEX PROSTHESES REVISED DUE TO ASEPTIC LOOSENING SECONDARY TO OSTEOLYSIS. 28 CHARNLEY CUPS- EXAMINATION OF THE EXPLANTED CUPS IDENTIFIED POLYETHYLENE WEAR. 29 CHARNLEY STEMS CAPTURED IN THIS COMPLAINT: CHARNLEY CUP: IMPLANT LOOSENING OF AN UNKNOWN INTERFACE, IMPLANT BEARING WEAR. FEMORAL HEAD: NO REPORTED PRODUCT PROBLEM. CHARNLEY STEM: IMPLANT LOOSENING OF AN UNKNOWN INTERFACE. PATIENT HARMS: OSTEOLYSIS, SURGICAL INTERVENTION, MEDICAL DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212845 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention