New unity record created in order to update etq complaint number (b)(4).New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.Litigation papers allege: bilateral patient was implanted with depuy pinnacle hip implant in her left hip on (b)(6) 2006, and in her right hip on (b)(6) 2006.The patient's hips are defective and have caused damage to her hip joints and her body.Doi: (b)(6) 2006 - dor: unk (left side).Doi: (b)(6) 2006 - dor: unk (right side).Patient is a resident of (b)(6).Update: (b)(6) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified by invoice search.Records are available for further review.Patient demographics added.Update ad 02 may 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 metallosis, metal wear and elevated metal ions.Updated the date of implant and event date.Added date of revision, revision hospital, revision surgeon, law firm, lawyer and expiration dates to the head and liner products.Added cup, stem, apex hole eliminator and bone screws due to alleged elevated metal ions and they were removed in the ppf.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (left hip).Please 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.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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