An article/literature was received entitled "cemented revision hip arthroplasty using strut and impacted cancellous allografts¿.Update 3 sep 2019.¿cemented revision hip arthroplasty using strut and impacted cancellous allografts¿ was reviewed for mdr reportability.The study followed 24 patients who have undergone hip revision due to severe loss of the femoral bone with the use of a cemented stem with a combined use of cortical strut and impacted cancellous allograft.All patients were available for follow-up at a minimum of 5 years post-revision.An elite plus cement stem was used on all patients.The manufacturer of the cement and cup/liner is unknown.The only acetabular component mentioned in the article is a competitor product.It is noted specific patient identifiers nor specific revision information was provided.The following adverse events were noted: 1.Femoral stem subsidence and loosening at an unknown interface.2.Infection, pain, stiffness, and dislocation.
|
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 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.Product complaint # (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.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, a follow-up medwatch will be filed as appropriate.
|