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Catalog Number 101204030 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Swelling (2091); Discomfort (2330); Depression (2361); Test Result (2695); Not Applicable (3189)
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Event Date 04/24/2013 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).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 that the patient suffers from pain, discomfort, inflammation, popping and difficulty ambulating.Update 3/24/2017 - pfs and medical records received.After review of the medical records, in addition to what was previously reported, litigation also alleges pain, popping, stiffness, swelling, difficulty sleeping and walking, pain caused by metal ion release, scarring, inability to lift leg when entering car, hip feels like it may collapse, depression.Bilateral hips revised simultaneously for pain and elevated ions.Revising surgeon noted upon entering the fascia in both hips "significant scarring".No metallosis, pseudotumor, osteolysis, trunnionosis, or implant loosening identified in operative record.No metal ion labs available to corroborate reported metal ion elevations.Prod/lot updated and stems for both hips added to complaint.Elevated metal ions harm added to all products.The complaint was updated on: 4/12/2017.
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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.Depuy considers the investigation closed at this time.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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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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In addition in what was previous alleged.Ppf alleges high metal ions.Added lawyer.However ,there was no laboratory values for metal ions.
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Manufacturer Narrative
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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 will be filed as appropriate.
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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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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. udi: (b)(4).
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Search Alerts/Recalls
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