The literature article entitled, "cement venogram¿a risk of satisfactory cement pressurization" written by damian mcclelland, bsc, frcs(tr and orth), and david bracy, fracs published by the journal of arthroplasty vol.21 no.1 2006 was reviewed.The purpose of the article was to report on a case report of a (b)(6) woman who had a left hybrid tha in june 2004 receiving depuy pinnacle cup, poly liner, charnely elite stem with cement restrictor and non-depuy cement utilized.A stainless steel femoral head was applied.Postoperatively, she developed clinical and radiological evidence of a right middle lobe pneumonia.She received antibiotic therapy and chest physiotherapy.On day 3 it was noted that cement was present within vessels on the medial side of the femur.She made a full recovery from pneumonia 6 weeks post op.The article reports that a undersized femoral prosthesis was utilized which increased the cement mantle along with the distal position of the cement plug may have been contributing factors to the cement gaining entry into the vascular system.
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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