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.
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The manufacturer became aware of a literature published by hallym university sacred heart hospital in korea.The title of this report is ¿clinical outcomes of u-blade gamma3 nails used to treat patients with trochanteric fractures: retrospective multicenter study¿ published in july 2019, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at http://dx.Doi.Org/10.5371/hp.2019.31.2.95.This report includes research done on 129 patients between the period september 2015 and may 2018.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 cut-out followed by hemiarthroplasty.The report states: resurgery was required in two subjects (1.6%).One presented with cut out of the femoral head at three months after operation [¿] and the other was a metal failure due to secondary injury at one month after surgery [.] both were converted to hemiarthroplasties.
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