BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4654380 · Received April 2, 2015

    Report

    Report Number
    0002249697-2015-01053
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    June 27, 2014
    Report Date
    March 10, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN CENTRAX DURATION . AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. -COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, X-RAYS, OPERATIVE REPORTS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. DISPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BIPOLAR CUP MIGRATION, THA WAS PERFORMED WITH ALLOGRAFT ON (B)(6) 2014. STEM WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220184 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention