Catalog Number UNK_KIE |
Device Problems
Separation Failure (2547); Malposition of Device (2616)
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Patient Problem
Impaired Healing (2378)
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Event Date 01/31/2019 |
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.Device disposition is unknown.
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Event Description
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The manufacturer became aware of a literature published by donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.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 migration of femoral neck screw followed by revision.The report states: ¿in one patient with lateral migration of the femoral neck screw, insufficient bone quality and delayed fracture healing, a change in procedure to a total hip prosthesis system took place as the method of choice.¿.
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Event Description
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The manufacturer became aware of a literature published by donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.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 migration of femoral neck screw followed by revision.The report states: ¿in one patient with lateral migration of the femoral neck screw, insufficient bone quality and delayed fracture healing, a change in procedure to a total hip prosthesis system took place as the method of choice.¿.
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Manufacturer Narrative
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Correction: please refer to section h6 (device code and conclusion code).This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged migration mentioned in the article could not be confirmed, however, the literature clearly indicates that the bone quality was insufficient and healing process was delayed, so it can be concluded that the root cause of the event is patient related.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Search Alerts/Recalls
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