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 a clinic.The title of this report is ¿to cement or not to cement: outcomes of two implantation techniques in three designs of radial head replacement in the acute fracture setting¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between 2005 & 2015.It was not possible to ascertain specific device details from the report, 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 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses loosening of the prosthesis followed by revision surgery.3 out of 6 cases.The report states: ¿in the quasi-anatomic group 16 were cemented and 12 were uncemented.In this group 1 of 16 cemented prosthesis was revised for loosening whereas 5 out of 12 in the uncemented group were revised (p<.05).¿.
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