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Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Naturally Worn (2988)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 02/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Pinnacle mom litigation records received alleging that the friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the plaintiff's blood and tissue and bone surrounding the implant resulting in inflammation, pain, discomfort, injury, partial or complete loss of mobility and loss of range of motion.Doi: (b)(6) 2009 - dor: (b)(6) 2019, (right 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.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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