BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR LONG NECK

    MDR report key: 3601328 · Received January 13, 2014

    Report

    Report Number
    9616680-2014-00124
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    July 25, 2012
    Report Date
    December 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    RA 2012-067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED AS PART OF THE MAR. THE REPORT CONCLUDED: THE NECK TO STEM TRUNNION OF THE MODULAR NECK EXHIBITED INDICATIONS OF MICRO-MOTION AND CORROSION INDICATING A MECHANICALLY ASSISTED CORROSION PROCESS TAKING PLACE. THE SIDE MOST AFFECTED WAS THE MEDIAL SIDE OF THE NECK TO STEM TRUNNION. THE BASE ALLOY WAS FOUND TO BE A (B)(4). NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED FAMILY. THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL RA 201-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    OBSERVED MODULAR ABG STEM REMOVAL BY DR WALKER AT CONCORD HOSP. DUE TO 5CM SIMUS DERMAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26676 ABGII MODULAR LONG NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2985279

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other