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.The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) and implanted before stryker became the legal manufacturer.On april 1, 2015 stryker became the legal manufacturer of the star system and has taken the responsibility for the medical device reporting.Device disposition is unknown.
|
The manufacturer became aware of a literature from (b)(6).The title of this report is ¿total ankle replacement in 35 cases¿ which is associated with the stryker ¿star¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from march 1999 to november 2006.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 10 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses unstable ankle joint introversion.1 out of 2 cases.The report states: ¿when examined the range-of-motion of ankle joint, we found unstable ankle joint introversion in 2 patients, which were caused by weakness and injury of lateral collateral ligament, so we externally fixed the lateral collateral ligament using plaster slab for 3 weeks so as to balance soft tissue.¿.
|