BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHP ALL POLYETHYLENE CUP 28MM X 46MM

    MDR report key: 6096575 · Received November 11, 2016

    Report

    Report Number
    3002806535-2016-00834
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    June 7, 2013
    Report Date
    October 12, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK960984
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00832, 00833, 00834).

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT HIP REVISION APPROXIMATELY 3 YEARS POST-IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM AND ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747700 SHP ALL POLYETHYLENE CUP 28MM X 46MM PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 1429332

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R