Product complaint # (b)(4).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.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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Surgeon removed acetabular cup, liner and head.Reason for operation was pain, metallosis, pseudo tumour and mal positioning of acetabular cup.Primary surgery was performed by dr.At hospital.I am trying to source more information on the implants removed as i have very limited information.I didnt know that it was a 50 cup, metal liner and 36 head, but i do not know specific product names or references.I am currently searching more information to complete this report.Patient status/ outcome / consequences? yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? metallosis and pseudo tumour.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? yes.Is the patient part of a clinical study? unknown.(b)(4).Device property of? none.Device in possession of? none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst? true.
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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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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