The reported event can be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿there is little radiolucence around the tibial and the talar component.The hcp reports, that some impingement together with some gutter is clinically identified as the problem.Also a ¿slight rotational malalignment is suspected to be the cause of the pain for the patient.There might be a little rotational alignment, however, it is a little prominent laterally, but it is difficult to say that a clinical problem results from this.¿ 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.According to the hcp, there is little radiolucence around the tibial and talar component.The hcp reports, that some impingement together with some gutter is clinically identified as the problem.Also a slight rotational malalignment is suspected to be the cause of the pain for the patient.There might be a little rotational alignment, however, it is a little prominent laterally, but it is difficult to say that a clinical problem results from this.If device is returned or any further information is provided, the investigation report will be reassessed.
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