DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Catalog Number 136507000 |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Hearing Impairment (1881); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
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Event Date 03/01/2019 |
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.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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The patient was revised to address mom pain.Doi: unknown, dor: (b)(6) 2019, 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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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Litigation records alleges metallosis and loss of hearing.After review of medical records, the patient was revised for failure of total hip with pain, one episode of dislocation, metal-metal problems with elevated cobalt and chromium levels, psuedocyst formation.Operative notes reported that there were egress of black thin fluid.The liner was not concentrically reduced and was askew in relative to the retroversion to the cup.
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Manufacturer Narrative
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Product complaint # (b)(4).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. h10 additional narrative: added a2, b5, b7, d1, d2, d4, d6, g5 (510k), h4, and h6.No code available (3191) is used to capture (device revision or replacement and blood heavy metal increase).
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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.Added: h6.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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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. 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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