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.
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The manufacturer became aware of a literature from (b)(6), 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/patient 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 polyethylene fracture followed by its exchange.2 out of 10 cases.The report states: ¿nine ankles (6.5%) required 10 polyethylene exchanges for component fracture at an average 8.9± 3.3 years post operation.One of these patients sustained 2 of these fractures, requiring polyethylene exchange.All polyethylene component fractures presented after an acute episode of pain following a fall, and none of these patients went on to tibial or talar component failure.¿.
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