"literature article entitled, ¿601 metal-on-metal total hip replacements with 36 mm heads a 5 minimum year follow up: levels of armd remain low despite a comprehensive screening program¿ by amit atrey, et al, published by journal of orthopaedics (2017), vol.14, pp.108-114, was reviewed.The purpose of this article is a retrospective study to assess the clinical outcome, failure rate, and reason for failure of a large consecutive series of 36 mm mom corail/pinnacle total hip replacements (thrs).Implanted depuy products: pinnacle cup, metal liner, cocr femoral head, and corail stem.Results: 100 patients had elevated blood metal ions greater than 7 ppb.The mean cobalt level was 120 ppb and chromium level was 135 ppb.These patients were given additional screening with ultrasound and aspirate of the periarticular joint fluid.12 of these patients were revised and captured in case 1-case 2.There were incidences of elevated blood metal ions in the revisions for dislocation, infection, and loosening.6 head and liner revisions due to dislocation.4 revisions due to infection.The components revised were unspecified.1 patient requested revision due to elevated blood metal ions.2 stem and head revisions due to limb asymmetry.4 revisions due to aseptic loosening of either the cup or head.Captured in (b)(4): pinnacle cup: implant loosening.Acetabular liner: implant dislocation.Femoral head: implant dislocation.Corail stem: implant loosening.Patient harms: surgical intervention, medical device removal, elevated blood metal ions, joint dislocation, inadequate osseointegration, limb asymmetry, infection.This article provides detailed information for 12 patients who were revised due to armd as evidences by elevated blood metal ions, histological confirmation of armd using hip aspirate, or ultrasound evidence of pseudotumor/pseudocapsule.These patients are captured in the attached guidance document labeled case 1-case 12.The parent (b)(4) captures the revisions and results not identified by patient." (b)(6) female implanted with a corail/pinnacle mom tha.Patient was revised due to armd, groin pain, and an ultrasound identified cystic mass.Intraoperative findings revealed thickening of the periarticular fluid without a pseudotumor, soft tissue necrosis, and alval.The armd was confirmed intraoperatively.Blood metal ions were under 7 ppb.The cup, liner, and head were explanted.There was no reported product problem with the femoral stem.
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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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