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 (b)(6) medical center, usa.The title of this report is ¿a review of perioperative complications of outpatient total ankle arthroplasty¿ which is associated with the stryker ¿star¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from october 2012 to may 2016.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 wound breakdown followed by nonrevision surgery (debridement with flap coverage).The report states: ¿the wound complication rate for outpatient taa was 1.5% (n = 1 of 65).This patient had a history of polycythemia vera (pv) with rethrombosis of their ipsilateral popliteal artery stent 1 month after taa surgery.The patient required debridement with flap coverage.[¿] this instance was attributed to arterial occlusion in the operative leg of a patient with pv and most likely not the outpatient operative management given that the wound complication developed 1 month after surgery.¿.
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