"literature article entitled, ¿porous-coated cementless acetabular cups in revision surgery: a 6- to 1 1-year follow-up study¿ by eduardo garcia-cimbrelo, md, phd, published by the journal of arthroplasty (1999), vol.14, no.4, pp.397-406, was reviewed.The purpose of this article was to review the efficacy of various types of acetabular bone grafting utilized during revision surgery performed between 1986 and 1991.The cups used in the index and revision surgeries were from various manufacturers.The authors utilized an unknown number of screws and unknown bone graft to secure the revision cups.The femoral components used are unknown.The authors used constrained liners assumed to be of the same manufacturer as the cup.There is insufficient information provided to determine the actual number of depuy products associated with the adverse events and radiographic findings noted within the article.Index tha components: 2 acs cups revised due to loosening of the bone to implant interface.Revision components: 14 duraloc cups paired with constrained liners and secured with an unknown number of acetabular screws.Re-revisions and interventions: an unknown number of cups and screws were revised due to cup loosening at the bone to implant interface.3 duraloc cups were identified as ¿mechanical failures¿ due to pain.Treatment was unspecified.Progressive radiographic findings: unknown number of cups and screws were identified as migrated, loosened at the bone to implant interface.There were radiolucent lines found in one or more delee-charnley zones.6 hips had radiographically identified broken screws.Fig.6 on page 404 and fig.4 on page 402 provides radiographic images of unknown loosened cups and broken screws.".
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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.Additional narrative: 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 will be filed as appropriate.
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