Model Number 1217-32-050 |
Device Problems
Use of Device Problem (1670); Malposition of Device (2616)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 07/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Pinnacle mom litigation records received.Litigation alleges friction and wear between the cobalt-chromium metal head and liner caused toxic metal ions and particles to be released into the patient's body resulting to injury, pain, discomfort, weakness on her hip, loss of mobility and loss of range of motion.Doi: (b)(6) 2010; dor: (b)(6) 2018; 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 will be filed as appropriate.
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Search Alerts/Recalls
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