The literature article entitled, "cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial" written by a.S.Gavaskar, n.C.Tummala, and m.Subramanian published by musculoskeletal surg (2014) 98:205¿208 doi 10.1007/s12306-013-0296-6 on 4 august 2013 was reviewed for mdr reportability.The article reports on patients greater than 80 years old who received tha between march 2006 and january 2009 with depuy implants.Group i consisted of 31 patients with cemented c-stem with ogee cup and group 2 consisted of 31 patients with cementless duraloc shell augmented with screws and a poly liner with collarless corail or summit stem.The femoral head was 28mm metal without indication of platform but suggestive towards depuy product.Nine total patients died with 3 in the perioperative period (all in group 1) with one dying during cementing process mid surgery and 6 unrelated to implants or procedure.Group i had the following results and complications that required interventions: 20 transfusions, 1 calcar intra-op associated to 1 dislocation due to subsidence attributed to calcar fracture who required revision, 1 acetabular aseptic loosening requiring revision.Group 1 also had noted complications without clarification of specific interventions provided: 1 etopic ossification, 1 dvt, 1 pe, 1 acute renal failure, 1 silent mi, 2 cardiac ischemia, and 1 pulmonary infection.Group 2 had the following results and complications that required interventions: 15 transfusions, 3 intra-op fractures treated with cerclage wiring, 2 dislocations with closed reductions and immobilizations.Group 2 also had noted complications without clarification of specific interventions provided: 1 dvt, 1 acute renal failure, 1 cardiac ischemia, and 1 pulmonary infection.The article does not identify product name of cement.
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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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