(b)(4).Concomitant medical products: unk comprehensive reverse humeral stem cat#ni lot#ni; unk comprehensive reverse glenosphere cat#ni lot#ni; unk comprehensive reverse baseplate cat#ni lot#ni; unk comprehensive reverse humeral tray cat#ni lot#ni.Acott, thomas r.Md, brolin, tyler j.Md, azar, frederick m.Md.(2020).A quantitative analysis of deltoid lengthening and deltoid-related complications after reverse total shoulder arthroplasty: a retrospective case-control study.Current orthopaedic practice, 31(2), 126-132.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 - 00236, 0001825034 - 2021 - 00237, 0001825034 - 2021 - 00238, 0001825034 - 2021 - 00240.
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It was reported in a journal article from current orthopaedic practice (2020), which reviewed deltoid complications after rtsa, that 4 patients experienced persistent deltoid pain with or without tightness later than 2 years after surgery.Patients were noted to have significantly more deltoid lengthening than patients in the control group at 26.3mm (range 17.6-35.6).2 patients complained of persistent deltoid pain and tightness.There were no subsequent surgeries or further complications in these patients.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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