Reported event: it was reported through the submission of primary and revision usage sheet's that the patient's left knee was revised.In comparing the sheets, a 6x9 cr insert was exchanged for another 6x9 cr insert.Update: "reason was infection.No further information will be given due to hospital policy." product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review a review of device history records shows that rob was inspected on 30/05/2012 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review a search of the complaint database under device identification pn (b)(4), rob reports no similar complaints for tka software ¿ other.Conclusions: it was reported that the patient's left knee was revised due to infection.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened h3 other text : device not returned.
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