(b)(4).Concomitant medical products: unknown liner; unknown head; unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03308.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
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Complaint sample was evaluated and the reported event was not confirmed.No product was returned, visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.The dislocation, impingement, and liner fracture most likely occurred due to the malposition shell.However, as medical records were not provided, the event could not be confirmed and a definitive root cause could not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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