Catalog Number 136553000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Edema (1820); Unspecified Infection (1930); Pain (1994); Swelling (2091); Joint Dislocation (2374); No Code Available (3191)
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Event Date 11/20/2006 |
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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Ppf and medical records received.Ppf alleges infection, dislocation with open and closed reduction.After review of medical records, patient was revised to address infection.Operative notes reported pain and swollen hip.Revision notes reported of gross purulence a large number of ''rice bodies'' granulation tissue.Doi: (b)(6) 2005, (head, stem).Doi: (b)(6) 2004, (cup, screws, liner).Dor: (b)(6) 2006, (left hip).(b)(4) (left hip 1st revision), (b)(4) (left hip 2nd revision), (b)(4) (left hip 3rd revision), (b)(4) (left hip 4th revision).
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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.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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