BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MDM/ADM LINER

    MDR report key: 7032493 · Received November 15, 2017

    Report

    Report Number
    0002249697-2017-03330
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 15, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: LFIT V40 28MM HEAD; CAT# UNKNOWN; LOT# UNKNOWN; RESTORATION MODULAR STEM 21MM X 195MM STRAIGHT; CAT# UNKNOWN; LOT# UNKNOWN; CONE BODY 27MM X 21MM; CAT# UNKNOWN; LOT# UNKNOWN; MODULAR DUAL MOBILITY INSERT; CAT# 626-00-52H; LOT# UNKNOWN; TRIDENT HEMISPHERICAL CLUSTER 64MM; CAT# 502-01-64H; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813236 UNKNOWN MDM/ADM LINER HIP IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R