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 hospital (b)(6).The title of this report is ¿causes for early and late surgical re-intervention after radial head arthroplasty¿ which is associated with the stryker rhead recon prosthesis.Within that publication, post-operative complications/ adverse events were reported which occurred from 2002 to 2014.It was not possible to ascertain specific device catalog and patient information from the study, 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 13 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses implant removal due to painful loosening.4 out of 5 cases.
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