DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Model Number 1365-52-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Neuropathy (1983); Pain (1994); Weakness (2145); Discomfort (2330); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 03/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 mom litigation received.Litigation alleges elevated metal ion levels, pain, disfigurement, loss of enjoyment of life and lifestyle, economic losses, and discomfort in both hips.Metal ion levels shows above 7ppb.Doi: (b)(4) 2006 - dor: (b)(4) 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.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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Event Description
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Plaintiff fact sheet and medical records received.In addition to what were previously alleged, pfs alleges sleeping difficulty, mental disorientation, mild dementia, neuropathy limited mobility and fatigue.After review of medical records, it was stated that the patient underwent a revision surgery to remove the metal-on-metal construct.Patient complains of discomfort, pain and parasthesia.Revision notes reported a 10ml reddish brown fluid, and the anterior portion of the gluteus medius tendon was a little weak; 2 anchors were used to keep the gluteus medius from pulling away from the trochanter.Doi: (b)(6) 2006.Dor: (b)(6) 2019.Left hip.
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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. h6 patient code: no code available (3191) used to capture device revision or replacement patient code.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: 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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