Catalog Number 121887458 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Distress (2329); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Litigation alleges toxic elevated metal ions, metal particles, metal wear, black fluid, soft tissue dissection, metallosis resulting to pain, emotional trauma, distress and injuries.Doi: (b)(6) 2010; dor: (b)(6) 2021; right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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Event Description
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After review of the medical records received, patient was revised to address toxic effect of metal, metallosis and elevated metal ions.Operative note reported that there was a large amount of blackened fluid in the iliotibial band and gluteal fascia were markedly soft and ill-defined secondary to inflammatory process.There was a hole in the greater trochanter with metallosis stain and had micromotion when moving however stable.There was a black stained tissue and osteolysis at the posterior region of the cup.Clinical visit reported inflammation of the hip, metallosis, elevated metal ions, cystic in greater trochanter region, weakness and hip pain.Lab result for metal ions were above 7 ppb.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H10 additional narrative: added: b5, h6 (clinical code).
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Event Description
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Medical records received.After review of the medical records received, patient was revised to address toxic effect of metal, metallosis and elevated metal ions.Operative note reported that there was a large amount of blackened fluid in the iliotibial band and gluteal fascia were markedly soft and ill-defined secondary to inflammatory process.There was a hole in the greater trochanter with metallosis stain and had micromotion when moving however stable.There was a black stained tissue and osteolysis at the posterior region of the cup.Clinical visit reported inflammation of the hip, metallosis, elevated metal ions, cystic in greater trochanter region, weakness and hip pain.Lab result for metal ions were above 7 ppb.Also, after review of medical records patient alleges stiffness, soreness, tenderness and swelling.Doi: (b)(6), 2010.Dor: (b)(6), 2021.Right 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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Medical records received.On (b)(6) 2021, patient was revised due to toxic effect of metal, undetermined intent, initial encounter.Operative noted an osteolysis at the posterior cuff region of the cup.Specimens obtained consisted of the femoral had and liner and a large of soft tissue metallosis.Patient cobalt and chromium levels were significantly elevated with cobalt in 12 ppb range and chromium with 31 ppb range.
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Search Alerts/Recalls
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