BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3678710 · Received March 14, 2014

    Report

    Report Number
    0002249697-2014-00763
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    February 6, 2013
    Report Date
    February 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ALUMINA INSERT REF 241243. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING AN UNKNOWN ALUMINA INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, PATIENT MEDICAL RECORDS AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT TO THE (B)(6): "A (B)(6) PATIENT, FRACTURE OF THE CERAMIC INSERT OF A NON-CEMENTED TOTAL HIP PROSTHESIS IMPLANTED ON (B)(6) 2004. THE FRACTURE WAS VISIBLE ON X-RAY TAKEN ON (B)(6) 2011 BUT THE PATIENT HAS COME FOR CONSULTATION MORE THAN ONE YEAR AFTER. NECESSARY TO PERFORM A REVISION SURGERY TO CHANGE THE INSERT ON (B)(6) 2013."

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT TO THE (B)(4): "A (B)(6) PATIENT, FRACTURE OF THE CERAMIC INSERT OF A NON-CEMENTED TOTAL HIP PROSTHESIS IMPLANTED ON (B)(6) 2004. THE FRACTURE WAS VISIBLE ON X-RAY TAKEN ON (B)(6) 2011 BUT THE PATIENT HAS COME FOR CONSULTATION MORE THAN ONE YEAR AFTER. NECESSARY TO PERFORM A REVISION SURGERY TO CHANGE THE INSERT ON (B)(6) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152798 UNKNOWN_CORK_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R