BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 2925507 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00161
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ALTR INVOLVING AN ABGII MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND 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 ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    THE PATIENT IS SCHEDULED FOR REVISION SURGERY FOLLOWING A DIAGNOSIS OF ALTR. THE FOLLOWING MEASUREMENTS WERE MADE 27 MONTHS SINCE INDEX SURGERY: COBALT - 1.9; CHROMIUM - 1.1. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC. INFECTION WAS NOT DIAGNOSED. ALSO REPORTED VIA SALES REP (B)(6) 2013, PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DOCTOR REVISED PATIENT'S RIGHT HIP TO SECURFIT AND TRIDENT TRITANIUM.

    Description of Event or Problem · 1

    THE PATIENT IS SCHEDULED FOR REVISION SURGERY FOLLOWING A DIAGNOSIS OF ALTR. THE FOLLOWING MEASUREMENTS WERE MADE 27 MONTHS SINCE INDEX SURGERY: COBALT - 1.9; CHROMIUM - 1.1. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC. INFECTION WAS NOT DIAGNOSED. ALSO REPORTED VIA SALES REP (B)(6) 2013, PATIENT HAD ADVERSE LOCAL TISSUE REACTION. DOCTOR REVISED PATIENT'S RIGHT HIP TO SECURFIT AND TRIDENT TRITANIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30733 ABGII. MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G2970070

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R