(b)(4).Hartline, jacob t., brolin, tyler j., wan, jim y.(2020).The effect of subscapularis management technique on outcomes and complication rates following reverse total shoulder arthroplasty.Seminars in arthroplasty (30), 42-49.Https://doi.Org/10.1053/j.Sart.2020.04.005.Unk comprehensive reverse humeral stem cat#: ni lot#: ni, unk comprehensive reverse glenosphere cat#: ni lot#: ni, unk comprehensive reverse bearing cat#: ni lot#: ni, unk comprehensive reverse tray cat#: ni lot#: ni, the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00179 ,0001825034 - 2021 - 00180, 0001825034 - 2021 - 00182 , 0001825034 - 2021 - 00183.
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It was reported in a journal article from seminars in anthoplasty: jses (2020), which studied the effect of various subscapularis tendon management techniques following an rtsa, that 1 patient within the transosseous repair group underwent a reoperation with irrigation and drainage for wound dehiscence.Attempts have been made and additional information on the reported event is unavailable at this time.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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.
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