The reported event could be confirmed, since operative notes were provided for evaluation and match to the alleged failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing, or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs the user that: ¿periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components.¿ strictly based on the operative notes received, a formal medical opinion was requested from an independent healthcare expert.In this patient with good bone quality, aseptic loosening can be suggested (no preoperative suspicion mentioned, and no cultures taken intra-operatively).Nevertheless, a low-grade infection cannot be ruled out with certainty.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 if any further information is provided, the complaint report will be updated.
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