It was reported that the patient has a history of surgeries on his hip.I do not have previous operative reports, labs, or clinical correspondence to share.The history that is documented was stated to me by the surgeon.This patient had his er hip replaced in 2009 with a smith and nephew birmingham metal on metal hip replacement.This patient was revised in 2012 by the surgeon where the birmingham hip was explanted and a summit stem with a pinnacle cup.The patient began to have dislocation issues after that revision and seen the surgeon in 2013 where he received a 40mm hip ball and constrained liner for the pinnacle cup.This patient came and seen the surgeon in 2018 with discomfort in his hip.The surgeon has done labs over the last few years to monitor his co and cr levels.Over time the patients co cr levels elevated.The surgeon decided to revise the hip, he found the stem was impinging on the 10degree lip constrained liner and created metal debris in the hip.A new hip ball and a neutral constrained liner was implanted.The summit stem and pinnacle cup were left in situ.Doi: (b)(6) 2013; dor: (b)(6) 2020; right hip.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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