Catalog Number 3L92515 |
Device Problems
Loss of Osseointegration (2408); Biocompatibility (2886)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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Event Date 05/23/2012 |
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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney." (b)(4).
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Event Description
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Litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update ppf alleges loosening of stem, and elevated metal ions.Doi: (b)(6) 2010 - dor: (b)(6) 2012 (left hip).
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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.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.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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