It was reported that during an investigation study of journey ii and legion implants conducted by hospital/ doctor and not sponsored by s & n, 14 of 57 surgeries present a complaint (one surgery per patient).The complications were swelling, pain and infection.13 of the complaints were from journey ii patients and 1 of the complaints was from a legion patient.The hospital is blaming the sterilization process of cutting blocks.No further information is available at the moment.
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It was reported that during an investigation study of journey ii and legion implants conducted by hospital/doctor and not sponsored by sn, 14 of 57 surgeries present a complaint.The complications were swelling, pain and infection.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record, sterilization documentation and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The sterilization process, however, could not be ruled out as a possible contributing factor.The patient impact beyond the reported events could not be determined.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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