The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿as the surgeon performed an extensive release of soft tissues and the motion interfaces (arthroscopic debridement, capsular release, subacromial decompression, exostosis, removal of posterolateral acromion, and removal of sutures), i do not believe we can blame to inferior osteophyte to be the reason for the limited range of motion.The shoulder was still fine a couple of months before the ae was reported and osteophytes do not develop in such a short time".Moreover, an osteophyte can be defined as a bony outgrowth, that occurred usually adjacent to an area of articular cartilage damage in a joint, mainly affected by osteoarthritis or due to aging, a condition that causes joints to become painful and stiff.In this case, it is very unlikely that the device could have caused the reported event.¿ more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or any further information is provided, the complaint report will be updated.Device remains implanted in patient.
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