Litigation papers allege the patient suffered from pain, metallosis, fluid build-up, mental anguish and a limp.Update rec'd 1/14/2014: pfs and medical records received.A correct doi was given for the right implant.After review of the left revision operative note it confirmed metallosis.Update rec'd 8/25/2014: pfs and medical records received.A dor was provided for the right hip.The revision operative note for the left hip stated the metallosis was between the head and trunnion, not the head and liner.The left side stem is being added.The right side revision note also indicated metallosis, but between the liner and head.Update ad 31 jul 2018: (b)(4) been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear, metallosis, and elevated metal ions.
|
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.
|