BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 8659509 · Received May 31, 2019

    Report

    Report Number
    1818910-2019-94925
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED: "OUTCOMES OF A METAL-ON-METAL TOTAL HIP REPLACEMENT SYSTEM" BY GS MATHARU, K THEIVENDRAN, PB PYNSENT, L JEYS, AM PEARSON, DJ DUNLOP PUBLISHED IN ANN R COLL SURG ENGL 2014; 96: 530¿535, WAS REVIEWED FOR MDR REPORTABILITY. THE STUDY ANALYZED THE OUTCOMES OF METAL ON METAL THR SYSTEMS INVOLVING THE CORAIL STEM, PINNACLE CUP, ULTRAMET LINER, AND ARTICULEZE FEMORAL HEAD. 578 UNCEMENTED HIPS WERE FOLLOWED IN THE STUDY. 39 HIPS FROM 38 PATIENTS WERE REVISED WITHIN A MEAN TIME OF 3.5 YEARS. THEY WERE IDENTIFIED BY AGE/GENDER. PATIENT #2 WAS A (B)(6) YEAR OLD FEMALE REVISED FOR DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452120 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention