"literature article entitled, ¿clinically significant corrosion at the head-neck taper interface in total hip arthroplasty: a systematic review and case series¿ by alberto carli, et al, published by hip international (2015), vol.25, no.1, pp.7-14, doi: 10.5301/hipint.5000180, was reviewed for mdr reportability.The purpose of this study is to provide a comprehensive systematic review of the published medical literature in order to determine which patient characteristics, surgical complications, implant designs are most strongly associated with modular head-neck corrosion as well as which treatment strategies have been utilized during revision surgery.Furthermore, the authors have also encountered patients with substantial modular head-neck corrosion in their own practice.They present six case studies that are captured within this complaint.The study group consisted of 4 men and 2 women with an average age of 74 ± 8.3 years.Demographic, surgical and histological findings per patient are summarized in the individual case studies within the attached guidance document.Patients presented at a mean of 5.89 ± 2.76 years after index tha.The implanted components included pinnacle 300 acetabular shells (depuy) of 50 mm diameter or greater, and prodigy femoral stems (depuy) of size 13.5 or greater.Bearing surfaces included metal highly cross-linked polyethylene in 3 patients (patient 1, 2 and 3), metal-on-cross-linked polyethylene in 1 patient (patient 4), and a mom in 2 patients (patient 5 and 6).Both mom patients and one metal-on-highly-cross linked polyethylene patient received 36 mm cocrmo heads, while the remaining patients received 28 mm cocrmo heads.Presenting symptoms among patients consisted of groin pain and a palpable mass (patient 2, 3 and 4), and recurrent dislocation (patient 1, 5 and 6).All patients underwent evaluation for serum markers for infection.Evidence of infection was found in patient 3.Final reports indicated that all patients exhibited large fluid collections around the hip joint consistent with adverse local soft tissue reactions.Serum metal ion levels in the two patients with mom bearings revealed elevated cobalt levels (34.09 ¿g/l and 81.59 ¿g/l) and normal chromium levels (6.75 ¿g/l and 3.69 ¿g/l).A large amount of fluid, usually yellow-brown in color, was encountered upon entering the hip joint.Intraoperatively, substantial corrosion of the femoral head-neck junction was encountered for all 6 patients, photographic evidence in fig.2, pp.11.Upon cleaning the trunnion, it was found to be structurally intact and the original stem was kept in place for all cases.The acetabular component was also well fixed in all cases.All patients underwent revision of the femoral head component to a ceramic femoral head with a constrained polyethylene liner.Histological investigation exhibited evidence of tan-grey or tan-yellow friable tissue with evidence of necrosis in all 6 cases.A diagnosis was made of aseptic lymphocyte dominated vasculitis associated lesion (alval) in 1 patient with a mom bearing surface.This complaint captures the author¿s report of their surgical cases.The complaint excludes the synopsis of reviewed medical literature on the subject, per reportability guidance.This complaint captures 6 total patients including this parent pc, labeled case 1-case 6.Please link all pcs to this parent (b)(4).Implanted products and patient consequences are captured in each complaint." (b)(6) yo male patient.Implanted with 52-mm pinnacle 300 cup, 16.5 standard prodigy stem, xlpe standard neutral 28-mm liner, and 28-mm/ +15.5 femoral head.Revised head and liner 6 years and 4 months after index tha for altr and recurrent dislocation.Intraoperative pathology: grey-tan-yellow capsular fluid, 94.8 cm3 pseudotumor (altr), and necrotic tissue.No evidence of infection.Corrosion found at the femoral taper of the head and stem.No aval.No pain reported before surgery.The stem was cleaned and left in situ.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Visual examination of the provided photographs on (b)(4) confirmed the reported event.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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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