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 is unknown.
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The manufacturer became aware of a literature published by (b)(6) hospital for joint replacement, in (b)(6).The title of this report is ¿total ankle replacement: a population-based study of 515 cases from the finnish arthroplasty register¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://doi.Org/10.3109/17453671003685459.Within that publication which included 217 cases, post-operative complications were reported, which allegedly occurred between 1997 to 2006.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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses 10 cases of aseptic loosening of tibia followed by revision.
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