Catalog Number 136536310 |
Device Problems
Metal Shedding Debris (1804); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Discomfort (2330); Injury (2348); No Code Available (3191)
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Event Date 03/07/2016 |
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.(b)(4).(b)(6) 2013.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Patient was revised due to a pseudotumor.
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Manufacturer Narrative
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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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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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.
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Event Description
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Pinnacle litigation records received.Litigation alleges that friction and wear between the metal head and metal liner caused the release of toxic metal ions into the patient's body resulting to injury, pain, discomfort, soreness and inability to perform activities of daily living.Doi: (b)(6) 2008; dor: (b)(6) 2016 (right hip).
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Manufacturer Narrative
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(b)(4).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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Event Description
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Patient was revised due to a pseudotumor.Update ad 04 jun 2018: (b)(4) has been re-opened under (b)(4) due to receipt of pinnacle litigation records.Litigation alleges that friction and wear between the metal head and metal liner caused the release of toxic metal ions into the patient's body resulting to injury, pain, discomfort, soreness and inability to perform activities of daily living.Stem added due to reported metal ions.Doi: (b)(6) 2008; dor: (b)(6) 2016 (right hip).See (b)(4) for the left hip.
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Event Description
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Ppf alleges metal wear/metallosis.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. udi: (b)(4).
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Search Alerts/Recalls
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