Please note the correction of the d1, d4 catalog, d9/h3.The complaint could be confirmed, since the returned information for evaluation matches the alleged failure, although the product wasn't returned for evaluation.Medical profession reviewed the received information and noted: the x-ray suggests that the initial alignment was already in varus.There is some radiolucency around the talar dome, may be indicative of beginning of loosening.X-ray not of medical grade, yet talus looks relatively white, suggests osteonecrosis (also some over projection of the fibula over the talus that makes interpretation more difficult.Additional information from sales representative received: the patient got revised, as the primary infinity implants got implanted in varus of 13°, based on a user related issue.All primary tar implants got revised, otherwise it could not be ensured that the alignment will be correct.All primary tar implants were discarded after the revision, no notes about item and lot numbers available.There is no information that this was also a patient or device related issues.No further information is available.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a use related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device discarded.
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