The reported event that stryker rhead was alleged that the patient died could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information is available.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no relation could be established between the product and the resulting adverse consequence.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
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The manufacturer became aware of adverse events from the norwegian arthroplasty register (nar).The title of this report is ¿rhead reported in the norwegian arthroplasty register (nar)¿ which is associated with the rhead system, within that report, post-operative complications/ adverse events were reported, which occurred between 2002 and 2017.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 3 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses death after the primary operation, the exact the date of the death will not be disclosed.2 out of 2 cases.
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