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 elda university hospital, in spain.The title of this report is ¿outcomes of cementless joint prosthesis versus tendon interposition for trapeziometacarpal osteoarthritis: a prospective study¿ which is associated with the stryker ¿ivory modular prosthesis¿ system.Article can be found on https://journals.Sagepub.Com/doi/10.1177/1753193418787151.Within that publication which included 84 patients, post-operative complications were reported, which allegedly occurred between 2012 to 2015.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 loosening of cup and pain followed by revision.The report states: ¿another patient, who presented with loosening of the cup and pain, was revised to a new prosthesis at 23 months after operation.¿.
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