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 unknown.
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The manufacturer became aware of a post market clinical follow-up report received from the (b)(6) center, in usa.The title of this report is ¿remotion total wrist arthroplasty: retrospective evaluation of outcomes during the first postoperative year¿ which is associated with the stryker ¿remotion total wrist system¿.This study includes research done on 21 patients requiring surgery between the period 2014 and 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses reduction of arc of active wrist flexion-extension from pre-operative (50) to post-operative (40).
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