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"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 a 54-mm pinnacle 300 acetabular cup, 15 standard prodigy stem, 36-mm +4 poly liner, and a 36-mm/+12 metal head.Revised cup and liner 2 years and 7 months after index tha due to a palpable groin mass and pain.Intraoperative findings: tan-grey intracapsular fluid with neutrophils.Evidence of infection and soft tissue necrosis.Pseudotumor size 125.5 cm3.No evidence of metal debris or aval.Corrosion of the head and stem taper.Stem cleaned and left in situ.
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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.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.Visual examination of the provided photographs on (b)(4) confirmed the reported event.Fretting and corrosion were visible on the trunnion and neck interface of both the femoral head and femoral stem.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 complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Investigational inputs were requested as indicated per internal procedures for this failure mode.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.
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