BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 4221409 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04103
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAY BY A CLINICAL CONSULTANT INDICATED: "CONFIRMED DISLOCATION ON ONE OF THE X-RAY PROVIDED" HOWEVER CLINICAL HISTORY AND OP REPORTS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A REVIEW OF PROVIDED X-RAYS BY A CLINICAL CONSULTANT CONFIRMED THE EVENT HOWEVER THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD ANOTHER REVISION DUE TO HEAD DISSOCIATED FROM THE POLY OF MDM.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD ANOTHER REVISION DUE TO HEAD DISSOCIATED FROM THE POLY OF MDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701198 RESTORATION ADM X3 INS 28/48 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 48363901

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention