(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02993.0001822565-2032-02994.0001822565-2023-02995.D10: unknown head; unknown cup; unknown liner.Proposed component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient reported not feeling well-flu like symptoms, low-grade fever, and pain.Articulating antibiotic spacer inserted.Hip is not draining, vac dressing removed, suture material removed.New hip components placed.The complaint is confirmed based on the provided medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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