STRYKER GMBH UNKNOWN STAR TIBIAL COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Injury (2348)
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Event Date 02/01/2008 |
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 sint maartenskliniek, in netherlands.The title of this report is ¿short-term results of our first 49 scandanavian total ankle replacements (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://journals.Sagepub.Com/doi/10.3113/fai.2008.0124.Within that publication which included 47 patients, post-operative complications were reported, which allegedly occurred between may 1999 to june 2004.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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses fracture of medial malleolus followed by revision.The report states: ¿one patient developed a stress fracture of the medial malleolus 19 months after her ankle replacement operation.This was successfully treated with internal fixation and debridement of the medial gutter.¿.
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