Patient was revised to address pain.Update: 6/3/13 - litigation papers received.Date of implant has been provided.There is no additional information that would affect the outcome of this investigation.Update rec'd 1/28/2014- pfs and medical records received.After review of the right hip revision operative note it confirmed metallosis.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 02/19/14.Update 24 jul 2018: (b)(4) was reopened under (b)(4) due to the receipt of ppf and medical records.In addition to what was previously reported, ppf alleges metal wear, metallosis and elevated metal ions.After review of medical records, no revision notes were provided.Added lawyer and law firm, patient middle initial, new ip (stem) and updated product details.Doi: (b)(6) 2011 - dor: (b)(6) 2013, (right hip).
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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).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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