(b)(4).Report source: united kingdom.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.Multiple reports are associated with this event.Please see associated reports: 0001825034 - 2022 - 02732, 0001825034-2022-02733, 0001825034-2022-02734, and 0001825034-2022-02735.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 visual examination of the provided photos identified the explanted products.However, due to the quality of the photo and as the devices were not returned, further analysis could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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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