Catalog Number 3L92511 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Cardiac Arrest (1762); Infarction, Cerebral (1771); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 09/29/2012 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Reason for original complaint.Patient was revised to address elevated ion levels.Stem loosening was also suspected; however, the stem was found to be well-fixed.Doi (b)(6) 2005 - dor (b)(6) 2012 (right hip).Litigation alleges pain, inflammation, bursitis, metallosis, nerve damage, lack of mobility, cystic lesions, tissue damage, bone erosion and pseudotumors.There is no additional information that would affect the outcome of this investigation.Records indicate that the patient was revised because of metallosis, elevated ion levels, and retroverted cup.In addition to what were previously alleged, ppf alleges metal wear, stroke and heart attack.Added stem due to heart attack and stroke.Doi: (b)(6) 2005 - dor: (b)(6) 2012 (right hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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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