New ecm record created in order to update legacy complaint (b)(4).New etq record created in order to update etq (legal system) complaint number wpc (b)(4).Reason for original complaint ¿ patient seeking legal action.Update: 12/23/2012 - litigation received 11/30/2012.Litigation alleges patient had pain, permanent physical injuries and disfigurement after asr hip implant.There is no new information that would change the outcome of the investigation.Update rec'd 1/19/2016: supplemental info recieved.A dor was received.The taper sleeve is now being added to the complaint.This complaint was updated on: 1/29/2016 update 1/21/16 medical records received.Case information form and component stickers reviewed for mdr reportability.There is no new additional information that would affect the existing investigation.The complaint was updated on: feb 12, 2016 update ad 10 sep 2019.(b)(4) has been reopened under (b)(4) due to receipt of medical records.After review of medical records, the patient was revised to address metallosis, erosion and loss of the short external rotators.Operative findings include a darkly-hued, bulging bursa full of metal debris, absence of 50% of the inferior external rotators, dense adhesions and scarring.The s-rom stem was noted to be well-fixed and there was no evidence of infection.Doi:(b)(6) 2006 - dor: (b)(6) 2013, (left hip).
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Product complaint # (b)(4).(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 will be filed as appropriate.
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