Operative notes were requested however none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.Single-use, sterilized devices manufactured or distributed by zimmer 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 highly unlikely that the specified device caused any patient infection.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer biomet considers the investigation closed.
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