BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3031979 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01173
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN CUP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. 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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE LOT CODE WAS NOT PROVIDED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE IN 1996. THE CUP HAD WORKED ITSELF LOOSE, BEADING CAME OFF THE BACK OF THE CUP. THE HEAD CAME OFF THE STEM. PATIENT HAD IN CONTINUITY IN ACETABULUM. THEY PLACED A ZIMMER CUP AND CAGE INTO THE ACETABULUM AND THE STEM WAS LEFT IN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE IN 1996. THE CUP HAD WORKED ITSELF LOOSE, BEADING CAME OFF THE BACK OF THE CUP. THE HEAD CAME OFF THE STEM. PATIENT HAD IN CONTINUITY IN ACETABULUM. THEY PLACED A ZIMMER CUP AND CAGE INTO THE ACETABULUM AND THE STEM WAS LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135600 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention