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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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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Component loosening occurred, with the subject reporting pain and contacting the surgeon's office.Radiographs revealed a broken inferior screw in the baseplate and shifting of the baseplate, which was confirmed by a ct scan.The subject underwent a revision procedure, and the outcome was resolved without any sequelae.Previous adverse events for this patient were recorded as anterior subluxation of the right shoulder with failure of the subscapularis repair and minimally displaced posterior inferior glenoid fracture.
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