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An event regarding altr involving an accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no products were returned for evaluation.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant revealed: " on april l, 2008 she underwent a primary right total hip arthroplasty for a diagnosis of "severe osteoarthritis right hip".A brief operative report describes spinal anesthesia and an anterolateral approach.On april 17, 2008 the patient was admitted with a "partial wound dehiscence, infected hematoma with mrsa".An incision and drainage was performed and it was noted, "no evidence of extension to deeper tissues were noted".On an office visit of may 5, 2016 the patient complained of right hip pain with a history of recurrent dislocation of the right total hip.Also on june 28, 2016 a consultation noted a left total knee in 2010 with complaints of recurrent instability of the right total hip with dislocations in 2015 and four more subsequently.On july 6, 2016 a mars mri of the right was performed for which the report states, "1.Extremely large joint effusion extending to the iliopsoas bursa with low signal nodular masses within the joint and region of the sacrosciatic patch.Causing mass effect on sciatic nerve and gluteal musculature.Consistent with altr and metallosis; and 2.Small region of abnormal signal anterior wall of acetabulum.No large areas of osteolysis, no loosening." on july 13, 2016 blood chromium was noted to be 1.7 (0.1 - 2.1 normal) and cobalt was noted to 9.1, which is elevated (0 -0.9).On july 25, 2016 a revision of the right total hip arthroplasty with excision of large "pseudotumor" was performed for a diagnosis of "failed right tha.Recurrent instability.Metallosis.Large pseudotumor.".The operative report describes general anesthesia and use of the previous posterior approach.The operative report notes, "doing well until august of 2015 when had the first dislocation in hyperflexion.Multiple pseudotumor debris.Completely filled.Hip joint.Head removed.Black metal debris at trunnion.Removed stem with flexible osteotomes.Posterior proximal femur bone most compromised by osteolysis and pseudotumor.Extended to anterior acetabulum.Acetabulum good position and well interfaced with the bone.Removed liner and screw, retained the shell.X-ray printouts available for review include two undated ap's of the pelvis, portable post-op, demonstrating bilateral uncemented total hip arthroplasties, reduced in nominal position, with one screw noted in the right acetabulum.There are two ap's of the pelvis and a lateral of the right hip, also undated, are unchanged from the previous description.There are multiple views of the right hip, all undated, some with the acetabulum on the right without a screw and some with a long stem uncemented monoblock component, reduced and in nominal position with a cerclage cable around the femur distal to the lesser trochanteric and up proximally over the greater trochanter.Additional x-ray printouts available for review include a series dated june 28, 2016, which are two ap's of the pelvis and one lateral of the right hip demonstrating bilateral uncemented total hip arthroplasties.The left is unchanged from the previous description and the right has one screw in the acetabulum with the hip reduced and in nominal position.X-rays dated july 25, 2016 are two ap's of the pelvis and one lateral of the distal half of the femur demonstrating bilateral uncemented total hips.The left is unchanged and the right now has a monoblock long-stem uncemented femoral component with no screws in the acetabulum.There is a cerclage cable from below the lesser trochanter medially to over the greater trochanter laterally.The hip is reduced and the components are in nominal position with skin staples in situ.X-rays dated september 6, 2016 are an ap of the pelvis and lateral of the right hip.They are unchanged from the previous description with the exception of no staples present.X-rays dated november 3, 2016 are an ap of the pelvis, times two, and a lateral of the right hip, which are unchanged from the previous films." -product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the reported event was not confirmed by medical review.Review of the provided medical records revealed that "there is no examination of the explanted components, no mars mri images available for review, and no histopathology confirming metallosis, altr or pseudotumor available for review.Modest elevations of blood and urine cobalt and chromium ions are not unexpected in a patient with three long-standing major joint arthroplasties and are not diagnostic of pathology.Based upon the information available for review, the clinical picture of post-operative incision and drainage for infection and hematoma, and subsequent late-term recurrent dislocations, has not been shown to be due to factures of faulty component design, manufacturing or materials." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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