BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9371130 · Received November 25, 2019

    Report

    Report Number
    1818910-2019-117213
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    June 28, 2005
    Report Date
    November 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. (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

    "LITERATURE ARTICLE ABSTRACT ENTITLED, ¿DETERMINATION OF CRYSTALLINITY AND CRYSTAL STRUCTURE OF HYLAMER POLYETHYLENE AFTER IN VIVO WEAR¿ BY M. VISENTIN, ET AL, PUBLISHED BY JOURNAL OF BIOMATERIALS APPLICATIONS (2006), VOL. 21, PP. 131-145, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE WEAR OF HYLAMER POLYETHYLENE LINERS EXPLANTED DURING CUP AND LINER REVISION. IMPLANTED DEPUY PRODUCTS: DURALOC CUP AND HYLAMER POLYETHYLENE LINER. THE FEMORAL COMPONENTS USED WERE UNKNOWN. RESULTS: THE AUTHORS REPORT ON THE POLYETHYLENE WEAR FOR 9 PATIENTS. ALL CUPS AND LINERS WERE REVISED DUE TO PAIN, ACETABULAR BONE EROSION, CUP LOOSENING, AND CUP MIGRATION SECONDARY TO EXCESSIVE WEAR OF THE POLYETHYLENE LINER. THIS COMPLAINT CAPTURES 9 INDIVIDUAL CASES LABELED CASE 1 THROUGH CASE 9. THE PARENT (B)(4) INCLUDES CASE 1. CASE 2 THROUGH CASE 9 ARE LINKED TO THIS PC. " (B)(6) FEMALE DURALOC CUP AND HYLAMER LINER REVISED DUE TO PAIN, ASEPTIC LOOSENING, CUP MIGRATION, AND ACETABULAR BONE EROSION SECONDARY TO EXCESSIVE POLYETHYLENE LINER WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165692 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention