Model Number 1217-01-050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 12/13/2021 |
Event Type
Injury
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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.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 complaint received ad 13 apr 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges injury, pain, dislocations, pseudotumor, muscle and tissue destruction, metallosis, metal wear, loss of enjoyment of life and limitation of daily activities.Doi: (b)(6) 2009, dor: (b)(6) 2021, unk hip.
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Event Description
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Medical records received.In addition to what was previously reported in the medical records active problem reported trochanteric bursitis, hematoma, depression and limited adl.Doi: (b)(6) 2009; dor: (b)(6) 2021; right hip first revision.
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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.H6: inflammation (e2326) is being utilized to capture bursitis.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 the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of photo, x-ray and video evidence provided found nothing indicative of a device nonconformance related issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device (121701050/df6ds1) product and lot numbers, and no non-conformances were identified.Device history review a manufacturing record evaluation was performed for the finished device (121701050/df6ds1) product and lot numbers, and no non-conformances were identified.
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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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Search Alerts/Recalls
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