Literature article received entitled, "improved survival of uncemented versus cemented femoral stems in patients aged\70 years in a community total joint registry." literature article entitled, ¿improved survival of uncemented versus cemented femoral stems in patients aged\70 years in a community total joint registry¿ by john wechter, md, et al, published by clinical orthopaedic related research (2013), vol.471, pp.3588-3595 was reviewed for mdr reportability.The healtheast joint registry (hejr) is a total joint registry that tracks hip and knee arthroplasties performed by 77 surgeons at five community hospitals in the st paul, mn, usa, metropolitan area.Information on 6498 hip arthroplasties was collected in the hejr between september 1, 1991, and september 30, 2011.All cemented and uncemented thas were considered for inclusion (n = 6498).Constructs with recalled acetabular implants (depuy asrtm, depuy, warsaw, in, usa; sulzer interoptm, zimmer, warsaw, in, usa) were included (n = 193); 4319 uncemented thas and 2179 cemented thas thus made up the study population.The constructs with recalled acetabular implants were included because the recalls were for the acetabular components, not the stems, and in no case was the failure of these acetabular component implicated in a stem failure.There were 135 stems that were revised, 64 uncemented thas and 71 cemented thas.Our outcomes of interest included stem revision for any reason (wear/osteolysis, aseptic loosening, periprosthetic fracture, infection, dislocation, failure of bone ingrowth, mechanical failure/breakage, instability, unexplained pain, or other) and stem revision for the combined reasons of aseptic loosening or loosening related to wear/osteolysis.The depuy products on the uncemented category were 1559 summit (12 revised) and 718 corail (9 revised).The stems in the cemented category were 165 summit (0 revised) and ultima (4 revised).The remaining stems within the study belonged to different manufacturers.Reasons for revision in the cemented cohort were; loosening caused by osteolysis, aseptic loosening, periprosthetic fracture, infection, dislocation, inadequate osseointegration, device fracture, pain, and unspecified other.The reasons for revision in the uncemented cohort were; loosening due to osteolysis, aseptic loosening, periprosthetic fracture, infection, dislocation, device fracture, and instability.The authors do not identify specific harms with specific products or manufacturers.Thirteen stems (seven cemented and six uncemented) were used in more than 100 cases with one uncemented stem (secure-fit1; stryker, kalamazoo, mi, usa) and one cemented stem (perfecta1; wright medical, arlington, tn, usa) demonstrating higher than expected cumulative revision rates.In the setting of a 20-year community joint registry, the authors found comparable crrs between cemented and uncemented stems when all reasons for revision were considered.When the focus was stem revisions performed specifically for aseptic loosening or loosening related to wear/osteolysis, uncemented stems demonstrated better survival in patients greater than 70 years old.Acetabular components were not identified, but the authors do mention the inclusion of the asr system and it is therefor included within the report.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).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.Device history lot: null.Device history batch: null.Device history review: null.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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