Catalog Number 122136056 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091); Joint Swelling (2356); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 09/17/2014 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Litigation papers allege the began experiencing symptoms of clicking and popping, swelling, and pain in 2014.Patient was therefore required to undergo her first of several revision surgeries.Beginning on or around (b)(6) 2014, the patient began undergoing a series of revision and infection-related procedures.
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Manufacturer Narrative
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\ no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Update 4/5/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported swelling, heat, pain, difficulty walking and standing, inability to climb stairs normally and unable to lift greater than 15 pounds.Medical records reported the patient with constant pain and loose femoral stem.Revision surgical note dated (b)(6) 2014 reported that patient had been nauseated, loose stem, an spiration with staph lugdunensis, and tensor had minimal damage after surgery.Part/lot updated.The complaint was updated on: apr 29, 2016.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Product complaint #: (b)(4).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. .
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Event Description
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Ppf alleges dislocation with open and close reduction.
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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 caused or contributed to the potential event described in this report.Udi: (b)(4).
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Event Description
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Ppf alleges fracture.
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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.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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