(b)(4).Medical product: compr nano hmrl pps 38mm, cat#: 115738 lot#: 952580, versa-dial/comp ti std taper, cat#: 118001 lot#: 335230, versa-dial 50x21x57 hum head, cat# 113053 lot#: 135080, md hybrid glenoid base 4mm, cat#: 113954 lot#: 380680, pt hybrid glen post regenerex, cat#: pt-113950 lot#: 497850.Customer has indicated that the device is in the process of being returned to zimmer biomet warsaw for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.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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It was reported that a patient underwent a left shoulder arthroplasty.Subsequently, humeral component radiolucency was noted at one (1) year post-operatively.The initial surgeon noted there was a gap present between the humeral component and humeral head implant during the initial procedure, due to an issue with a discrepancy between the trial head representation and the definitive humeral head implant.The surgeon states this may be leading to the radiolucency.
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