It was reported that a patient had revision due to the humeral adapter tray disassociating from the humeral stem.The screw remained intact between the humeral liner and tray and the threads on the stem were undamaged.A new adapter tray, liner, and torque screw were implanted with no complications.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00624 and 1038671-2017-00625.
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Upon review of all available information, the revision due to a humeral tray disassociation reported in experience c2017-468 was likely the result of inadequate seating of the torque screw at the time of initial surgery, which allowed for disassociation of the tray from the stem.Only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use the devices.The surgeon must be fully knowledgeable about all aspects of the equinoxe surgical technique and use these implants in accordance e with the respective indications and contraindications.In addition, the surgeon should be fully knowledgeable about the compatibility of system components and use each device accordingly.Also, the surgeon must be fully knowledgeable about the surgical technique and they must be trained according to the proper use of the system instrumentation.This device is used for treatment not diagnosis.No information, asked not provided.
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