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.
|
The manufacturer became aware of a literature published by rhode island hospital, in usa.The title of this report is ¿complications of short versus long cephalomedullary nail for intertrochanteric femur fractures, minimum 1 year follow-up¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at doi 10.1007/s00590-014-1557-2.Within that publication which involved 256 patients, post-operative complications were reported, which allegedly occurred from 2006 to 2011.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 (3) cases of trochanteric bursitis due to prominent lag screw followed by revision surgery.The report states: ¿four patients (one short nail, three long nail) required re-operation for prominence of the lag screw leading to trochanteric bursitis and were treated with exchange of the lag screw to one of shorter length.¿.
|