BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3111016 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01663
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE SINGLE X-RAY PROVIDED CONFIRMS A LOOSE ACETABULAR SHELL. MORE INFORMATION SUCH AS OP REPORTS, PROGRESS NOTES, AND MEDICAL HISTORY ARE NEEDED TO CONDUCT A MEANINGFUL CLINICAL REVIEW. THE INVESTIGATION CONCLUDED THAT THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES AND THE RETURN OF THE DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION. IT ALSO CONCLUDED THAT THERE IS NO INDICATION THE EVENT IS RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    SURGEON COMMENTED ON LOOSE CUP.

    Description of Event or Problem · 1

    SURGEON COMMENTED ON LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213284 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention