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.(b)(4).Device disposition unknown.
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The manufacturer became aware of a literature published by (b)(6) hospital, in (b)(6).The title of this report is ¿secondary surgery after total ankle replacement: the influence of preoperative hindfoot alignment¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found at https://www.Sciencedirect.Com/science/article/pii/s1268773106000919.Within that publication, post-operative complications were reported, which allegedly occurred from 1997 to 2004.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, 12 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses reoperation of ankle involving length adjustment of the fibula.
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