Catalog Number 563620 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Necrosis (1971); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 04/11/2016 |
Event Type
Injury
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Event Description
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Medical records received ad (b)(6) 2022.After review of medical records patient was revised was due to painful left metal on metal.Operative notes indicates a large effusion of clear joint fluid was released.Some necrotic tissue along the inferomedial hip was noted.Doi: (b)(6), 2009.Dor: (b)(6), 2016.Left hip.Please see (b)(4) for right hip.
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.If additional information is made available, the investigation will be updated as applicable.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Event Description
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Medical records were received: on (b)(6) 2016, underwent revision of his left hip due to extreme hip pain, groin pain, discomfort, and clicking sensation post operatively.Blood tests revealed that cobalt from the implant was slowly seeping into his blood stream and resulted in dangerously high levels.The elevated cobalt levels resulted in various health complications such as hypertension, generalized anxiety, nervousness and depression, fatigue, metal taste in his mouth, weight loss, forgetfulness, periodic itching sensation all over his body, among other issues which are attributable to the cobalt poisoning.On (b)(6) 2023.In addition to what was previously reported in the medical records, clinical visit reported assessment mild depression, cobalt toxicity, fatigue and arthritis.Doi: (b)(6) 2009, dor: (b)(6) 2016, left hip.
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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 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).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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