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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Report source is a literature article.There is limited information regarding the reported death(s).(b)(4).
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"literature article entitled, ¿the corail stem for the treatment of displaced femoral neck fractures - a viable alternative?¿ by derek t.Crawley, et al, published by hip international (2011), vol.22, no.2, pp.243-250, was reviewed.The purpose of this study was to investigate clinical and radiographic outcomes for a cementless tapered titanium fully hydroxyapatite-coated corail stem in a consecutive cohort of 68 hip fracture patients between january 2004 and november 2007.Implanted depuy products: corail femoral stem and 28-mm self-centering depuy bipolar femoral head.All patients were treated with displaced femoral fractures with hemiarthroplasties.Results: 1 superficial wound infection- treatment unknown.1 patient was revised due to stem migration caused by an undersized stem.4 mispositioned stems.1 periprosthetic fracture treated with cerclage.6 patients had residual pain requiring no treatment.2 radiographically identified stem migrations.There were 4 reported deaths within six weeks of hra surgery.Two were related to preexisting conditions- chronic renal failure and bleeding gastric ulcer- and are not included in this complaint.One patient died of a myocardial infarction 1-week postoperatively.Another patient with parkinson¿s disease died 10 days postoperatively from sepsis secondary to pneumonia.One patient with mental and physical comorbidities had a fall that led to recurrent dislocations.The fall was unrelated to the hemiarthroplasty.The patient died 317 days after surgery due to overwhelming pneumonia unrelated to the hemiarthroplasty.This death and fall are not included in the complaint.Captured in this complaint: corail stem infection, dislocation, fracture post-op, pain, pneumonia, myocardial infarction, migration, misposition; femoral head: dislocation, pain, pneumonia, myocardial infarction, and infection; femoral head: infection, myocardial infarction, pneumonia, pain.Corail stem, femoral head, and femoral head for death.".
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