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.
|
The manufacturer became aware of a study from (b)(6).The title of this report is ¿radial head replacement with unipolar and bipolar sbi system: a clinical and radiographic analysis after a 2-year mean follow-up¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between january 2009 and december 2010.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 22 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lack of 40° in extension and of 25° in flexion in patient (nr.19).2 out of 2 cases.The study states, ¿one (patient nr.13) had a slight limitation in the flexion¿ extension range (30¿140°) with a meps of 100 points and the last (patient nr.19) had a lack of 40° in extension and of 25° in flexion, but pronation and supination were satisfactory (140°) and the clinical result was excellent.¿.
|