DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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Catalog Number 121887354 |
Device Problems
Material Disintegration (1177); Insufficient Information (3190)
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Patient Problems
Necrosis (1971); Pain (1994); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Depression (2361); Not Applicable (3189)
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Event Date 03/22/2017 |
Event Type
malfunction
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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, pseudotumor, disability, physical impairment, disfigurement, mental anguish, aggravation of a previous condition, injury, tissue necrosis, heavy metal poisoning, loss of bone, emotional distress, anxiety, and depression.Doi: (b)(6) 2009; dor: (b)(6) 2017; 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.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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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).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.
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Search Alerts/Recalls
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