BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221368 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04093
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN CUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT CONFIRMED SHELL LOOSENING BUT COULD NOT DETERMINE A ROOT CAUSE. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING RETURN OF DEVICE, OPERATIVE REPORTS, MORE X-RAYS, PATIENT HISTORY, PROGRESS NOTES IS NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY ON HIP DUE TO CRACKED LINER.

    Description of Event or Problem · 1

    REVISION SURGERY ON HIP DUE TO CRACKED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701907 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention