(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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).
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"literature article entitled, ¿hydroxyapatite-coated versus grit-blasted femoral stems¿ by m.Hamadouche, et al, published by the journal of bone and joint surgery (2001), vol.83-b, pp.979-987, was reviewed.The aim of this prospective, randomized study was to evaluate the long-term stability of uncemented femoral components of the same design in two configurations, grit-blasted and hydroxyapatite-coated femoral stems in 50 hips implanted between may 1988-may 1990.Implanted depuy products: all patients were implanted with a profile stem, a trilock cup, a polyethylene liner, and a metal femoral head.Results: 1 hematoma treated with surgical evacuation.2 peroneal nerve palsies- treatment was unknown.The nerve palsies did not resolve completely.2 dislocations treated with closed reduction.1 recurrent dislocation secondary to a loosened cup- treated with cup revision.3 revisions of the cup and liner due to liner failure.In one, the liner fractured and in two the liner was worn through to the cup.In all 3 cases, the liner failure caused the head to articulate on the cup leading to intraoperatively identified metallosis and wear on the cup.The cup revision and metallosis was secondary to the liner failure.2 stems revised for loosening and stem migration.1 postoperative femoral fracture treated with orif and stem retention.10 intraoperative femoral fractures- 4 treated with cerclage.Radiographic findings: 29 cases of cortical hypertrophy, 10 mispositioned stems, 10 mispositioned stems, and 20 stem migrations.There were no patient consequences in the radiographically identified cases.Captured in this complaint: trilock cup: implant loosening/implant to bone.Polyethylene liner: implant fracture post op, implant bearing wear, implant dislocation.Femoral head: implant dislocation.Femoral stem: implant loosening, implant migration.Patient harms: hematoma, surgical intervention, medical device removal, joint dislocation, inadequate osseointegration, fracture, nerve injury.Femoral stem: implant migration, implant misposition.Patient harms: medical device site erosion.".
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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).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.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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