Catalog Number 136554000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neuropathy (1983); Pain (1994); Tissue Damage (2104); Injury (2348); Hypoesthesia (2352); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 pain, burning sensation, difficulty moving around, tingling and numbness, ringing ears, vision problems, bone loss and decreased mobility, metallosis, injury and disfigurement.Clinic visit notes alleges myalgia, neuropathy and low back pain.It was also alleged that lab results revealed elevated levels of cobalt and chromium in the blood; no values provided.
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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.Corrective action was not indicated.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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