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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The manufacturer became aware of a study from medical university of (b)(6).The title of this report is ¿migration of the lag screw after intramedullary treatment of ao/ota 31.A2.1-3 pertrochanteric fractures does not result in higher incidence of cut-outs, regardless of which implant was used: a comparison of gamma nail with and without u-blade (rc) lag screw and proximal femur nail antirotation (pfna)¿ which was published on 7-may-2019 and is associated with the stryker gamma nailing system.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device catalog or patient details from the article, 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 30 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses revision due to cut-out seven weeks post- primary.4 out of 6 cases.The study states, ¿the third patient, suffering a cut-out seven weeks post-primary intervention, was revised with a hemiarthroplasty.".
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