Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." (b)(4).This report is number 3 of 4 mdrs filed for the same patient (reference 1825034-2017-00470 / 00471 / 00472 / 00473).
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Patient has indicated pain, instability, immobility and tenderness at the 6 week and 3 month post-operative check-ups.Patient has also reported mild pain with slight immobility along with tingling and twitching in the cervical neck radiating posteriorly into the operative shoulder with an onset of approximately 2 years post-implantation.No revision has been reported to date.
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This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Concomitant medical product ¿ compr nano hmrl pps 40mm, cat#: us-115740 lot#: 115240; versa-dial/comp ti std taper, cat#: 118001 lot#: 667150; versa-dial 54x21x64 hum head, cat#: 113063 lot#: 159440; pt hybrid glen post regenerex, cat#: pt-113950 lot#: 450790; simplex p bone cement, cat#: ni lot#: ni.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04454, 0001825034-2017-04456, 0001825034-2017-04457, 0001825034-2017-04458, 0001825034-2017-00470, 0001825034-2017-00471, 0001825034-2017-00472, 0001825034-2017-00473.
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It was reported patient underwent a left total shoulder arthroplasty, subsequently pain, instability, and tenderness were noted at the six (6) week post-operative follow-up and continued instability was noted at the three (3) month post-operative follow-up.The issues had reportedly resolved by one (1) year post-implantation.No revision has been reported to date.
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