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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The manufacturer became aware of a literature published by department of clinical science and education, stockholm south general hospital in sweden.The title of this report is ¿is fast reversal and early surgery (within 24 h) in patients on warfarin medication with trochanteric hip fractures safe? a case-control study¿ which is associated with the stryker ¿gamma3¿ system.The article can be found at https://doi.Org/10.1186/s12891-018-2126-3.This report includes research done on 198 patients between the period january, 2011 and december, 2014.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 myocardial infarction in the patient on warfarin (anticoagulants) medication.
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