This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The following could not be completed with the limited information provided: date implanted - ni.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under pma number p010014.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." requested but not returned by hospital.
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