BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 2925403 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00126
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 10, 2012
    Report Date
    April 21, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    Z-2089/2090-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS ABGII MODULAR STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING HIGH COBALT LEVELS INVOLVING AN UNKNOWN ABGII MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. A SEARCH OF THE SUPER AND CHS COMPLAINT DATABASES COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. SIMILAR EVENTS HAVE OCCURRED FOR THE ABGII MODULAR PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED HIGH COBALT LEVELS IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CURRENTLY HAS HIGH LEVELS OF COBALT AND HIS CHROMIUM LEVELS ARE WITHIN RANGE. PATIENT STATES THAT HE HAS HAD BLOOD WORK AND MRI DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CURRENTLY HAS HIGH LEVELS OF COBALT AND HIS CHROMIUM LEVELS ARE WITHIN RANGE. PATIENT STATES THAT HE HAS HAD BLOOD WORK AND MRI DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30360 ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC MEH STRYKER ORTHOPAEDICS-MAHWAH G3064577

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other