(b)(4).Concomitant medical products: biomet taper insert cat#139254 lot#844730, biomet head cat#157446 lot#843560, biomet cup cat#us157852 lot#151290, biomet stem cat#11-103204 lot#939100.Reported event was confirmed with medical records provided.Review of the revision operative notes confirms that the patient had right revision due to pain and elevated metal ions.Operative notes states moderate serous fluid, no purulent fluid.No corrosion.No wear or loose bodies in socket.Scar tissue excised.Review of the device history records identified no deviations or anomalies during manufacturing.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.This device remains implanted in the patient.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04741.
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