Catalog Number 121887456 |
Device Problems
Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Joint Dislocation (2374); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 01/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Patient was revised to address pain and dislocation.Doi: 2008.Dor: (b)(6) 2018.Unknown hip.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Pinnacle litigation record received.Litigation alleges inflammation, pain and discomfort, including when ambulating or moving to and from a sitting position,friction and wear between the cobalt-chromium metal head and liner cause large amounts of toxic cobalt-chromium metal ions.
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Manufacturer Narrative
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Product complaint # = > pc-(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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