This complaint has been reported during a literature review performed by the post market surveillance group. 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.
Patient Sequence No: 1, Text Type: N, H10
The manufacturer became aware of a literature from usf health morsani college of medicine, united states. The title of this report is? Intermediate-term experience with the star total ankle in the united states? Which is associated with the stryker? Scandinavian total ankle replacement (star)? System. Within that publication, post-operative complications/ adverse events were reported, which occurred from january 1999 to 2013. It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 76 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses failure of implant followed by ankle fusion. 2 out of 4 cases. The report states:? Four of the 21 total failures occurred in patients who underwent elective explant and tibiotalar fusion because of continued unexplained ankle pain. No specific failure mode was able to be determined after review of radiographs and intraoperative findings at the time of implant removal.?
Patient Sequence No: 1, Text Type: D, B5