Catalog Number 121887350 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
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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.
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Event Description
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Pinnacle litigation received.Litigation alleges pain, metallosis, metal poisoning, lack of mobility, injury and disability, emotional distress, anxiety, depression, and a feeling looseness in her left hip.Doi: (b)(6) 2008; dor: not revised; left 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.Device history lot: null.Device history batch: null.Device history review: null.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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Event Description
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Ppf alleges loosening of stem and elevated metal ions.
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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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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 caused or contributed to the potential event described in this report.
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Event Description
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Updated patient harm.Doi: (b)(6) 2008 - dor: none reported (left hip).
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Search Alerts/Recalls
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