BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 8621245 · Received May 17, 2019

    Report

    Report Number
    1818910-2019-93923
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 NUMBER 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIP PAIN AND WAS REASON FOR REVISION SURGERY, PRIMARY WAS DONE AT UNKNOWN DATE AND LOT NUMBERS AS WELL AS REFERENCE NUMBERS COULD NOT BE READ. THE SURGEON PERFORMED A HEAD AND LINER CHANGE AND PATIENT HAD SOME OSTEOLYSIS BEHIND THE CUP AND SOME AROUND THE STEM , BOTH COMPONENTS WHERE STILL SOLID AND THE SURGEON BONE GRAFTED BOTH COMPONENTS. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414934 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention