Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); Fibrosis (3167); No Code Available (3191)
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Event Date 11/08/2010 |
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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After review of medical records, the patient was revised to address sceptic loosening of the acetabular component.It was also indicated that the patient has pain, walking difficulties, some tenderness, stiffness, discomfort, leg discrepancy, tendonitis and inflammation.Revision notes reported that frozen section came back as moderate polys with an intermediate suspicion for infection.A trochanteric osteotomy was created when the surgeon was trying to remove the prosthesis with a back-slapping s-rom extractor.Competitor antibiotic spacer, cables and revision prosthesis were implanted.Pathologic result shows fibrosis and heterotrophic ossification.Doi: (b)(6) 2007; dor: (b)(6) 2010; (left hip).
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Manufacturer Narrative
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(b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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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