The reported event could be confirmed, since images of ct scans were provided and shows signs of loosening around the tibial and talar components.A medical professional reviewed the received information and noted the following: ¿the tibial component shows some smaller cysts and cavities, a little radiolucence around the implant suggesting loosening.The reported ankyloses in the adjacent joints can be confirmed.The pe is not directly visible, but there are no clear signs of breakage or dislocation.The talar component shows the same signs of loosening as the tibial part, however, the bone stock here is explicitly poor with cysts, cavities all around the bone proving a bone metabolic disorder.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused by poor bone quality.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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