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 (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.
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The manufacturer became aware of a literature from dumc, united states.The title of this report is ¿polyethylene fracture following star ankle arthroplasty: a report of three cases¿ 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 february 2000 to december 2007.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 5 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses polyethylene meniscus fracture followed by revision.The report states: ¿in november 2007, his pain suddenly increased to the point that he was no longer able to bear weight on the right lower extremity.Radiographs at that time revealed a fractured polyethylene meniscus.In late november 2007, a polyethylene exchange was performed.The 6-mm polyethylene was noted to have suffered a coronal plane fracture [.] and was subsequently replaced with a thicker 7-mm polyethylene meniscus.¿.
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