Product complaint # (b)(4).11/18/2022 talked with the patient via phone to clarify the event description.The patient reported that he has bilateral shoulders that were put in 2017.The patient is have issues with his left shoulder.It dislocated, the ball came out of the socket.He had a manipulation and the shoulder went back into place, now it dislocates off an on.He is scheduled to have a revision.He has been experiencing pain.The patient provided his email address and home address so he may receive an authorization form.The patient would like to know if there has been any recalls with his products or any known issues.The device catalog number is unknown; therefore, udi is unavailable.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the -x-ray evidence was able to confirm, the complain.It is evident, that a dislocation event occurred, between the shoulder glenosphere and humeral cup.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.
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