(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.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.Corrective action was not indicated.(b)(4).
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"literature article entitled, ¿primary total hip replacement for acute displaced subcapital femoral fractures with a minimal three-year follow-up¿ by s.Sharma, et al, published by hip international (2005), vol.15, no.1, pp.33-37, was reviewed.The aim of the study was to review the results of total hip arthroplasty in patients with garden 3 and 4 fractures of the neck of femur implanted between 1993-2001.Implanted depuy products: 4 ultima stems paired with a cemented ultima polyethylene cup cemented with unknown cement; 2 charnley elite plus stems paired with a charnley elite plus polyethylene cup cemented with unknown cement; 2 pfr stems paired with a duraloc cup and enduron polyethylene liner.The femoral head used with these thas are unknown and assumed to be depuy products.There were 33 competitor stems and 35 competitor cups and liners used in this study.Results: the authors do not identify the manufacturer in the following results.The number of depuy products associated with the adverse events is unknown.1 intraoperative fracture treated with cerclage that resulted in postoperative limb asymmetry less than the reportable standard of 2 cm.1 perioperative femur fracture due to a fall 2 months postoperatively- treated with stem revision.This patient dislocated in the immediate postoperative period and required an additional revision of unknown components.I periprosthetic femur fracture secondary to a trauma 4 years postoperatively.There is insufficient information to attribute the trauma to the implanted devices.1 dislocation treated with closed reduction.1 thigh pain secondary to stem loosening treated with revision to a pfr stem.1 wound dehiscence- treatment unspecified.3 deep vein thrombi- treatment unspecified.1 pulmonary embolism- treatment unspecified.1 unspecified chest infection- treatment unknown.1 atrial fibrillation- no intervention required.There is insufficient information to attribute the atrial fibrillation to the surgical procedure or the implanted devices.There were additional complications of lung aspiration and erosive esophagitis not attributed to the surgical procedure or implanted devices.Captured in this complaint: duraloc locking ring: no reported product problem.Polyethylene cup: implant dislocation.Duraloc cup: no reported product problem.Polyethylene liner: implant dislocation.Femoral head: implant dislocation.Femoral stem: implant loosening.Patient harms: fracture, surgical intervention, medical device removal, inadequate osseointegration, pain, dvt, pe, infection, joint dislocation, fall, wound dehiscence.".
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