Complaint description: litigation alleges the patient suffers from large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone, pain, discomfort, immobility and inflammation.Update rec¿d 4/30/2014¿ pfs and medical records received.Part/lot was provided.After review of the medical records there is no new additional information that would affect the existing mdr decision.The complaint was updated on : 5/29/2014.Update received 05/13/2016 the sales rep has reported the revision surgery.Patient was revised to address pain.There is no new information that would change the existing mdr decision or investigation.Complaint was updated on 05/19/2016.Update ad 31 jul 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges metallosis, component fracture and infection.Added all other implants due to alleged infection.Account name, facility name, patient code, products expiration and udi were also added.Corrected event date.Doi: (b)(6) 2008- dor: (b)(6) 2016 (right hip).
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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.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.
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