Catalog Number UNK_SEL |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Debris, Bone Shedding (1803); Injury (2348)
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Event Date 01/01/1993 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been reported during a literature review performed by the post market surveillance group.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.Device disposition is unknown.
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Event Description
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The manufacturer became aware of a study from (b)(6) hospital, (b)(6).The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis.Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007.It was not possible to ascertain specific device or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 147 complaints was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses debridement of the gutters and stabilization of the ankle by ligament augmentation.16 out of 22 cases.The study states: "11 secondary surgical procedures were performed in each design group, the most common being debridement of the gutters and stabilization of the ankle by ligament augmentation and/or different osteotomies.
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Manufacturer Narrative
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Correction to section b5.
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Event Description
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The manufacturer became aware of a study from falun general hospital, sweden.The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis.Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007.It was not possible to ascertain specific device or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 147 complaints was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses debridement of the gutters and stabilization of the ankle by ligament augmentation.16 out of 22 cases.The study states: "11 secondary surgical procedures were performed in each design group, the most common being debridement of the gutters and stabilization of the ankle by ligament augmentation and/or different osteotomies.".
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Search Alerts/Recalls
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