STRYKER GMBH UNKNOWN STAR POLYETHYLENE COMPONENT; 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 01/04/2012 |
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 duke university medical center, in usa.The title of this report is ¿intermediate to long-term outcomes of the star total ankle replacement: the patient perspective¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on http://dx.Doi.Org/10.2106/jbjs.J.01613.Within that publication which included 82 patients, post-operative complications were reported, which allegedly occurred between july 1998 to february 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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses (3) cases of replacement of fractured polyethylene spacer with a new spacer.
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