BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM. CUP W/HA

    MDR report key: 2831064 · Received November 2, 2012

    Report

    Report Number
    9616680-2012-00987
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K072020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS: MFR #2249697-2012-02191 & MFR # 9616680-2012-00986.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, CASE SCHEDULED AS REVISION OF LOOSE CUP AS PT WAS COMPLAINING OF PAIN AFTER A FALL. WHILE IN SURGERY THE DR. CHECKED TAPER JUNCTION OF NECK AND STEM AND SAW DARK DISCOLORATION. DECISION WAS MADE TO REVISE ALL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM. CUP W/HA IMPLANT MEH STRYKER ORHTOPAEDICS CORK NA G3007986

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention