Unf and medical records received.After review of medical records, it was indicated that the patient complaints of persistent pain.X-rays show some osteolysis in the proximal femur, mri shows pseudotumor and some elevated cobalt and chromium levels.The patient was then revised for metallosis around a metal on metal left hip replacement.Operative notes reported that there was a large amount of slightly cloudy yellow fluid with some apparent debris in it.There was a fairly large pseudotumor.There was a fair amount of corrosion on the trunnion.It was noted that the s-rom component was placed significantly in anteversion and the sleeve was also in a lot of anteversion.There was some areas of osteolysis in the proximal femur and some osteolysis in the acetabulum superior and posterior wall.There were some small cavity defect behind the acetabulum.Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.
|
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.H10 additional narrative: corrected: h6(device code and closure codes).Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will 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.
|