The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a post market clinical follow-up report received from (b)(6) hospital, in usa.The title of this report is ¿a retrospective data collection of the replacement of the total wrist joint due to rheumatoid arthritis, osteo-arthritis or post-traumatic arthritis with remotion total wrist system¿ which is associated with the stryker ¿remotion total wrist¿ system.The treatment period of patients included in this report was between january 1, 2014 and december 31, 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 7 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses superficial infection 27 days after the surgery.The report states: ¿both events resolved without need for revision and caused no permanent disability other than possible flexion contracture for the patient with the infection who was later lost to follow-up.¿.
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