"the literature article entitled, ""corrosion at the stem-sleeve interface of a modular titanium alloy femoral component as a reason for impaired disengagement"" written by christian r.Fraitzl, md, luis e.Moya, md, lorenzo castellani, md, timothy m.Wright, phd, and robert l.Buly, md published by the journal of arthroplasty vol.26 no.1 2011 accepted by publisher october 25, 2009 was reviewed.The article's purpose was to report on examination of 22 modular titanium alloy femoral components retrieved.0 to 8.8 years in vivo.All implants were the srom stem.The article does not discuss or provide any information regarding femoral head, acetabular cups or bearing surfaces.The main focus was the retrieved stem with examination of the sleeve/stem interface for corrosion.Each case is captured individually along with reason for revision and note of corrosion." this complaint captures specimen 12 from a (b)(6) with implantation period of 1.8 years 13 mm stem size and reasons for revision was malfunction/mechanical complication ("clicking" of the hip while sitting).Note of corrosion with black metal debris noted on stem and sleeve interface.
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Visual examination of the provided photographs on (b)(4) confirmed the reported event.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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