(b)(4).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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Literature article entitled, ¿comparison of the risk of revision in cementless total hip arthroplasty with ceramic-on-ceramic and metal-on-polyethylene bearings¿ by claus varnum, et al, published by acta orthopaedica (2015), vol.86, vol.4, pp.477-484, was reviewed.The authors compared the 9-year revision risk for cementless coc tha and for cementless metal-on-polyethylene (mop) tha.The data used for this study was retrieved from the danish health registry for the dates january 1, 2002 through september 15, 2009.There were results for both depuy and competitor thas.Depuy products: 63 duraloc option cups using biolox forte articulating surfaces.41 pinnacle cups with biolox delta articulating surfaces.102 corail and 18 s-rom femoral stems.Results: this article does not specify manufacturer with adverse events.This complaint will only capture events associated with coc bearing failures and femoral stems as these were the depuy products identified in the study.9 stem revisions for periprosthetic fracture 22 revisions of head and liner for dislocation 6 total revisions for deep infection 10 revisions for aseptic loosening of the cup 9 total revisions for unspecified pain 2 head and liner revisions for impingement between stem and liner rim due to liner misposition 2 revisions for fracture of both liner and head 3 head and liner revisions for fracture of ceramic head 1 liner revision for fracture of ceramic liner 2 revisions of head and liner due to squeaking of the hip.Captured in this complaint: stem, head, liner, cup, and femoral augment.The authors identify one patient implanted with a depuy tha labeled (b)(6) female.This patient is included in the attached guidance document.Please link patient labeled (b)(6) female to parent pc-000584239.
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