STRYKER GMBH UNKNOWN STAR TIBIAL COMPONENT,; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number UNK_SEL |
Device Problem
Unstable (1667)
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Patient Problem
Injury (2348)
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Event Date 07/01/2011 |
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 small bone innovation, inc., (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 (b)(6) bone and joint specialist, in usa.The title of this report is ¿correction of moderate to severe coronal plane deformity with the star¿ ankle prosthesis¿ which is associated with the stryker ¿star¿ ankle¿ system.The article can be found at https://doi.Org/10.3113%2ffai.2011.0659.Within that publication which included 130 patients, post-operative complications were reported, which allegedly occurred from january 2000 to december 2009.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 lateral ankle instability which required calcaneal osteotomy and a posterior tibialis tendon transfer to the peroneus brevis.The report states: ¿the final patient had a history of charcot-marie-tooth disease and had undergone prior lateral ligament reconstruction (brostrom) and a lateral closing wedge calcaneal osteotomy 3 years prior to her ankle replacement.Her lateral ligament complex was stable at the time of tar but she developed lateral ankle instability subsequent to the tar.She underwent another closing-wedge calcaneal osteotomy and a posterior tibialis tendon transfer to the peroneus brevis 8 months following the index procedure.She developed a 20-degree recurrent varus deformity and was deemed a radiographic failure.¿.
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