BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3163135 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01884
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL KEPT IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION, HISTORY REVIEW OR COMPLAINT HISTORY WAS PERFORMED AS NO DEVICES WERE RECEIVED OR IDENTIFIED. A PRIMARY OPERATIVE REPORT WAS PROVIDED FOR REVIEW. NOTHING CAN BE LEARNED FROM THIS DOCUMENT. INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE REPORTED EVENT REGARDING WEAR INVOLVING AN UNKNOWN POLY WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLY WORE OUT. REPLACED POLY'S HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLY WORE OUT. REPLACED POLY'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264427 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R