H3, h6: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, per subsequent e-mail, this complaint was source from a literature review and no further information is available.Therefore, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, patient condition, and post-operative healing issue.The contribution of the devices to the reported events could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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