New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- litigation alleges that patient has experienced pain, difficulty walking, loosening of the implant, popping in hip, numbness, tingling, and weakness.Doi: (b)(6) 2006 dor: none reported (left side).Patient is a resident of (b)(6).Update: 11/19/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update 2/17/16-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The revision operative note indicated pain and synovitis.There was no mention of loosening.The right hip ((b)(4)) was revised for elevated metal ion levels-no labs), so the stem will be added to this hip as well.The complaint was updated on: 3/4/2016.Update ad 24 april 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.Ppf alleges loosening of cup and stem, metal wear and metallosis.Added cup 121722056, lot # at3f11000.Doi: (b)(6) 2006; dor: (b)(6) 2015; (left hip).(b)(4)-left hip.(b)(4)-right hip.
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(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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