(b)(4).D10 ¿ unknown ms-30 stem item#unknown, lot#unknown.Unknown head item#unknown, lot#unknown.G2 ¿ foreign ¿ new zealand.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00442, 0009613350-2023-00444. the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : device discarded.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product is discarded.
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