STRYKER GMBH UNKNOWN STAR POLYETHYLENE COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number UNK_SEL |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problem
Injury (2348)
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Event Date 10/10/2006 |
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.
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Event Description
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The manufacturer became aware of a literature published by falu hospital, in sweden.The title of this report is ¿secondary surgery after total ankle replacement: the influence of preoperative hindfoot alignment¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found at https://www.Sciencedirect.Com/science/article/pii/s1268773106000919.Within that publication, post-operative complications were mentioned, which allegedly occurred from 1997 to 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, 12 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses (4) cases of instability and worn out polyethylene bearing followed by revision, out of (109) patients.The report states: ¿the most frequent reasons for revision were instability with dislocation or subluxation of the polyethylene insert [¿] all cases revised because of instability showed considerable wear of the polyethylene component as a results from edge loading¿.
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Search Alerts/Recalls
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