(b)(4).Medical product: compr nano hmrl pps 32mm, cat#: 115732 lot#: 105060, versa-dial/comp ti std taper, cat#: 118001 lot#: 412450, versa-dial 42x21x43 hum head, cat#: 113034 lot#: 365150, sm hybrid glenoid base 4mm, cat#: 113952 lot#: 985740, pt hybrid glen post regenerex, cat#: pt-113950 lot#: 090900.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 reported at six (6) weeks and six (6) months 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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(b)(4).The following report is submitted to relay additional information.The reported event is confirmed, as x-ray reviewer stated "humeral component radiolucency was noted at 6 weeks and 6 months post-implantation." only the trial humeral head was returned for evaluation.Visual inspection identified that both screw heads were at, or below flush prior to disassembly.Dimensions taken were within specification.Device history record (dhr) was reviewed and no discrepancies were found.No issues could be found with the returned trial head.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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