Complaint description: new etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint: patient had a reaction to metal.Update rec'd 5/19/2015: litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, discomfort, and difficulty walking.Update 11/20/2015: pfs and medical records received.Pfs and medical records reviewed for reportability.Pfs reported difficulty with activities of daily living, emotional distress, consequences related to metal ion exposure, painful itchy rash, dislocations, hip fracture, confined to wheelchair, loss of independence and homebound.Medical records and revision surgical report noted swelling in left groin, large fluid collection, necrosis of tissue and muscle, metal reaction and weakness.There were no lab tests for metal ions within medical records reviewed.There was no report of dislocation or hip fracture in revision surgical report.Update ad 05 sep 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2009 (left hip).This pc is for the first revision of the left hip.Please see (b)(4) for the second revision and (b)(4) for the third revision.Patient is bilateral.See (b)(4) for the 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.
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