Catalog Number 121725500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 08/28/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Event Description
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Litigation alleges patient suffers from pain, discomfort, inflammation, and toxic cobalt chromium metal ions.Update 2/10/2016- pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated the patient was revised for infection and pain and all implants were removed on (b)(6) 2015.At this time infection isn't alleged per litigation.Part/lot is being updated and the cup and screws are being added to the complaint as mdr nos.No labs were provided for the alleged high metal ion levels.Update (12/5/2016) ¿ pfs and medical records received.After review of the medical records for mdr reportability, it was noted in the initial revision ((b)(6) 2015) that surgeon identified "significant damage to the anterior femoral cortex with involvement of this caseous necrosis-type process." caseous necrosis is defined as a necrosis without infection, indicating that the then current infection process wasn't the cause of the necrosis.Update ad 8 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges metal wear and metallosis.Doi: (b)(6) 2010 - dor: (b)(6) 2015, (left hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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 : null device history batch : null device history review : null 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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Search Alerts/Recalls
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