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.(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 abstract entitled, ¿determination of crystallinity and crystal structure of hylamer polyethylene after in vivo wear¿ by m.Visentin, et al, published by journal of biomaterials applications (2006), vol.21, pp.131-145, was reviewed.The purpose of this article was to evaluate the wear of hylamer polyethylene liners explanted during cup and liner revision.Implanted depuy products: duraloc cup and hylamer polyethylene liner.The femoral components used were unknown.Results: the authors report on the polyethylene wear for 9 patients.All cups and liners were revised due to pain, acetabular bone erosion, cup loosening, and cup migration secondary to excessive wear of the polyethylene liner.This complaint captures 9 individual cases labeled case 1 through case 9.The parent (b)(4) includes case 1.Case 2 through case 9 are linked to this pc." (b)(6) y/o male duraloc cup and hylamer liner revised due to pain, aseptic loosening, cup migration, and acetabular bone erosion secondary to excessive polyethylene liner wear.
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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, a follow-up medwatch will be filed as appropriate.
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