(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01432.G2: foreign: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h6, and h10.Corrections in section d9.
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