Catalog Number 157002110 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Anemia (1706); Headache (1880); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330)
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Event Date 03/30/2017 |
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 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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Aug 2, 2017: litigation received.Litigation alleges discomfort, pain, walking with a limp, decreased range of motion, elevated cobalt-chromium in the blood, and pseudotumor.Part and lot information were provided.
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Event Description
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Pfs and medical records received.In addition to what was previously alleged, pfs alleges metallosis, anemia, disability in doing adl, no energy and constant headaches.After review of the medical records for mdr reportability, it was reported that the patient was revised due to metal on metal reaction.Revision notes reported a large pseudotumor, 500ml of fluid, metallosis reaction and acute inflammation.
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Manufacturer Narrative
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No device associated with this report was received for examination.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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Event Description
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Complaint description: aug 2, 2017: litigation received.Litigation alleges discomfort, pain, walking with a limp, decreased range of motion, elevated cobalt-chromium in the blood, and pseudotumor.Part and lot information were provided.Update: 8 nov 2017: pfs and medical records received.In addition to what was previously alleged.Pfs alleges metallosis, anemia, laboratory confirmed of high cobalt and chromium, no energy and constant headaches.After review of the medical records for mdr reportability, it was reported that there was degenerative joint disease with avascular necrosis with collapse.Revision notes reported of large pseudotumor, metalosis reaction and acute inflammation.This complaint was updated on nov 15, 2017.
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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).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.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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