BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 2925388 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00150
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE NO MEDICAL INFORMATION WAS PROVIDED. THE MATERIAL ANALYSIS REPORT CONCLUDED THAT THE STEM SHOWED BONY ON-GROWTH ON ALL SIDES OF THE STEM AND THE INTERFACE AT THE NECK TO STEM JUNCTION SHOWED NOTHING REMARKABLE. IN ADDITION, THE NECK TO HEAD TRUNNION SHOWED AN AS-MANUFACTURED SURFACE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE EXAMINED SURFACES. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT OR CATALOG NUMBER. SIMILAR EVENTS HAVE OCCURRED FOR THE PRODUCT FAMILY. NONE ARE RELATED TO DESIGN, MANUFACTURING, OR MATERIAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE. WERE ORIGINALLY GOING TO CABLE IT BUT DECIDED THAT SINCE IT WAS AN ASYMPTOMATIC ABGII STEM IT WOULD BE REMOVED ANYWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERI PROSTHETIC FRACTURE. WERE ORIGINALLY GOING TO CABLE IT BUT DECIDED THAT SINCE IT WAS AN ASYMPTOMATIC ABGII STEM IT WOULD BE REMOVED ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30662 ABGII. MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G2981322

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R