The reported event that 16 patients required revision surgery due to loosening could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the national registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the australian registry are not published reports and therefore web link is not available.
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