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 pmcf from reno orthopedic clinic, united states.The title of this report is ¿utilization of the stryker hoffmann limb reconstruction frame in patients with complex foot and ankle conditions.¿ which is associated with the stryker ¿hlrf¿ system.Within that publication, post-operative complications/ adverse events were reported.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 10 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses implant loosening followed by revision.6 out of 6 cases.The report states: ¿one patient (case 4) who had two episodes of pin loosening.This patient had a recurrence of his symptoms and went back again for pin site wash out and an exchange of the carbon ring for an aluminum ring which ultimately resolved these issues.¿.
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