Model Number 1217-25-500 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Edema (1820); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 11/04/2013 |
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 elevated toxic cobalt chromium metal ions, pain, discomfort, and inflammation.Update ad 17 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.There were no new allegations.Added lawyer, law firm, account name, dob, date of event and product details.Corrected patient identifier.Doi: (b)(6) 2010; dor: (b)(6) 2013; (right hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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