STRYKER GMBH UNKNOWN STAR POLYETHYLENE LINER; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number UNK_SEL |
Device Problem
Fracture (1260)
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Patient Problem
Injury (2348)
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Event Date 11/05/2014 |
Event Type
Injury
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Manufacturer Narrative
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¿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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Event Description
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The manufacturer became aware of a literature published by university of alberta, in canada.The title of this report is ¿outcome of total ankle arthroplasty in patients with rheumatoid arthritis and noninflammatory arthritis ¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found with pubmed id 25378503.Within that publication, post-operative complications were reported, which allegedly occurred between november 2001 to december 2008.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore 7 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses cases of fractured polyethylene liner (in noninflammatory arthritis group) followed by its exchange.
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Search Alerts/Recalls
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