Model Number 56-3620 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Metal Related Pathology (4530)
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Event Date 02/23/2015 |
Event Type
Injury
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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.Initial reporter occupation: lawyer.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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Medical records received ad (b)(6) 2022: after review of medical records patient was revised was due to painful hip, discomfort, secondary to metal on metal wear.Operative notes indicated elevated ions however the results were below normal level and multiple vague complaints.There was some metallosis at the trunnion.The only area of obvious metal wear was on the trunnion.Doi: (b)(6) 2009, dor: (b)(6) 2015, 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.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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Event Description
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In (b)(6) 2015, patient underwent revision of his right 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.
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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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Event Description
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Medical records received.After review of the records, clinical visit reported assessment mild depression, cobalt toxicity, fatigue and arthritis.
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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).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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