(b)(4).Concomitant products: item name: unknown oxford femoral component; item#: unknown; lot#: unknown; item name: unknown oxford bearing; item#: unknown; lot#: unknown; investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2022 - 00375, 3002806535 - 2022 - 00377.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2,h6, h10 no products were returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for the 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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