BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 8227704 · Received January 8, 2019

    Report

    Report Number
    1818910-2019-80189
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    December 11, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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

    PRODUCT COMPLAINT # (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 COMPLAINT IS THAT THE STRIP WITH THE FIRST CUP REF (B)(4), LOT 8926267 DID NOT SIT PROPERLY AND THE CUP WAS DISCARDED AND AVAILABLE TO RETURN. A SECOND CUP REF (B)(4), LOT 8873537 WAS OPENED AND THE SAME PROBLEM EXPERIENCED. IT WAS IMPLANTED WITHOUT THE X-RAY MARKER AS NO OTHER IMPLANTS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17854 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1