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 study from (b)(6) united states.The title of this report is ¿association of short-term complications with procedures through separate incisions during total ankle replacement¿ which is associated with the stryker ¿star prosthesis¿.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2007 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 41 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses osteolysis treated with curettage and allograft bone grafting followed by poly exchange and debridement.2 out of 2 cases.The report states: ¿additional procedures performed through the anterior incision included all of the 5 lateral ligament repairs, all of the 4 hardware removals, and 2 of the procedures, which included bone grafting of cystic defects during revision procedures[.] [¿] all of the revision procedures used the prior anterior incision.Each revision consisted of a poly exchange and debridement; 2 of these patients with osteolysis were treated with curettage and allograft bone grafting.¿.
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