(b)(4).Report source united kingdom.Product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00610, 0001825034 - 2023 - 00612.Citation: kendrick, b.(2023).Post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study [review of post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study].Mdrg2017-89ms-95h(revision 0.2).
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - stem.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not 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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