Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Corroded (1131)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
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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.(b)(6).
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Event Description
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Litigation alleges that corrosion and friction wear between the implants caused toxic cobalt-chromium debris to be released into the patient's body resulting to injury, pain, inflammation, tissue and bone loss, limited mobility, loss of range of motion, mental anguish and diminished enjoyment of life.A blood-work order confirmed that patient's blood plasma had elevated chromium and cobalt levels.
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Manufacturer Narrative
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(b)(4).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 code(s) was not provided.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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