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 study from (b)(6) general hospital, (b)(6).The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis.Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007.It was not possible to ascertain specific device or patient details from the study, 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 147 complaints was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses revision due to aseptic loosening.20 out of 62 cases.
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