(b)(4).Report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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In a journal article published approximately one year ago, studying total elbow arthroplasty survivorship for arthritic patients under 55 years old, it was reported that 1 of 19 patients underwent a l ulnar revision due to aseptic loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
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Siala, m.Et al.Outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old.Journal of shoulder and elbow surgery.2019: 1-8.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.- attachment: [journal article.Pdf, outcomes of semiconstrained tea.Pdf, (b)(4) literature review.Pdf].
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