Catalog Number UNK_SEL |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inflammation (1932); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 01/01/2008 |
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) university of (b)(6).The title of this report is ¿terrible triad of the elbow: is it still a troublesome injury¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between 2008 to 2013.It was not possible to ascertain specific device details from the report, 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 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses ffs mobilization, olecranon bursitis, asymptomatic radial neck radiolucency (case 10).The study states: ¿a further two patients (cases 10 and 17) underwent a re-intervention owing to late ffs loosening and concomitant olecranon bursitis.One severe periprosthetic lucency was observed in a patient with radiographic signs of implant overstuffing and oversizing (case 10), which appeared between the third and the sixth months postoperatively and progressed until the third year of follow-up.This progression stopped thereafter, and new bone formation was observed.
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Manufacturer Narrative
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New information in section h6 (device code and patient code).
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Event Description
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The manufacturer became aware of a study from (b)(6) , italy.The title of this report is ¿terrible triad of the elbow: is it still a troublesome injury¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between 2008 to 2013.It was not possible to ascertain specific device details from the report, 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 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses ffs mobilization, olecranon bursitis, asymptomatic radial neck radiolucency (case 10).The study states: ¿a further two patients (cases 10 and 17) underwent a re-intervention owing to late ffs loosening and concomitant olecranon bursitis.One severe periprosthetic lucency was observed in a patient with radiographic signs of implant overstuffing and oversizing (case 10), which appeared between the third and the sixth months postoperatively and progressed until the third year of follow-up.This progression stopped thereafter, and new bone formation was observed.
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Search Alerts/Recalls
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