STRYKER GMBH UNKNOWN STAR TALAR 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 Problem
Injury (2348)
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Event Date 02/01/2000 |
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) hospital, in usa.The title of this report is ¿gutter impingement after total ankle arthroplasty¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/23520289.Within that publication which included 137 patients, post-operative complications events were reported, which allegedly occurred from february 2000 to june 2011.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 debridement after secondary gutter resection (sgr).The report states: ¿seven of all 34 patients (21%) had additional surgery related to the ankle replacement after sgr (3 had repeat debridement [¿] the 3 patients with repeat debridements had their second sgr at 5, 15, and 32 months later, respectively.¿.
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