The patient reported pain and decreased function, leading to a revision surgery.The reason for the revision surgery was listed as heterotopic ossification, severe stiffness, and nickel metal allergy.Components including the tray, insert, and glenosphere were explanted, while the stem, baseplate, and central screw were retained.The relatedness to the study device and the surgical procedure was assessed as possible.
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The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
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