The literature article entitled, "primary total hip arthroplasty using a modular proximally coated prosthesis in patients older than 70" written by scott m.Sporer, md, raymond j.Obar, rn, and philip m.Bernini, md published by the journal of arthroplasty vol.19 no.2 2004 accepted by publisher 22 august 2003 was reviewed.The article's purpose was to report on clinical and radiographic results on primary thas with modular proximally coated femoral components.Data was compiled from primary thas between december 1993 and january 1998 of 122 patients (135 thas) over the age of 70 years old.All implants were depuy products.The article provides generalized results but also identifies 2 patients in radiographic results which are captured individually in linked complaints.Depuy products utilized: srom stem, duraloc or ztt cups, cocr or ceramic heads, poly liners.This complaint captures the generalized findings of wound infection (treated by repeated irrigation and debridement), intraoperative non-displaced vertical fractures of metaphysis during sleeve insertion (no change in post operative protocol and fractures healed uneventfully without surgical intervention), dvt (treated with prolonged anti-coagulation), radiographic findings of osteolysis in femur and acetabulum (no interventions provided - article associates osteolysis with poly wear), radiographic of heterotopic ossification (no indication of negative impact to patient and no indication of intervention) the article does not provide adequate information to determine accurate quantities for the generalized adverse events.
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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 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, a follow-up medwatch will be filed as appropriate.
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