Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Naturally Worn (2988)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Pain (1994); Weakness (2145); Discomfort (2330); Test Result (2695); No Code Available (3191)
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Event Date 01/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No code available represents surgical intervention.
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Event Description
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Litigation alleges pain, spasms, weakness, friction and wear between cobalt-chromium metal head and liner caused toxic cobalt-chromium metal ions into the blood, tissue and bone, metal ions were abnormally high and discomfort.
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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. udi: (b)(4).
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Event Description
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Pfs alleges limping, weakness pain, bursitis and mental confusion.After review of medical records, the patient was revised for metallosis of the right hip, status post total bypass.Operative notes reported a pseudotumor.Trunnion was well preserved, although there was a little bit of graying material at the trunnion area.
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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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Search Alerts/Recalls
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