DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Catalog Number 136552000 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Skin Discoloration (2074); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360)
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Event Date 05/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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.Initial reporter: attorney.
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Event Description
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Der states that 36+5 cocr head and 36x60 ultamet liner removed and replaced (ceramic/poly) due to metal ion levels.Doi: unknown; dor: (b)(6) 2018; right hip.Ad 05 jul 2018: pinnacle litigation records received.In addition to what was previously alleged, litigation alleges discoloration and paleness in the skin, elevated metal ions, pain, disfigurement, distress and injury.
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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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Event Description
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After review of medical records, patient was revised to address increased pain and right hip metallosis.Revision stated, the head was found to have metal stained tissues and fluid.
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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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