It was reported that the patient's left hip was revised due to infection.All components were removed and a cement spacer was placed.The patient's original total hip was done (b)(6) 2020 and he had an i&d washout, head liner exchange, on (b)(6) 2020.Doi: (b)(6) 2020; dor: (b)(6) 2021; affected side: left hip.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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