Catalog Number 136554000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
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Event Date 12/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #(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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The patient was revised to address pain.Metal liner was removed and replaced with polyethylene.Doi: unknown ; dor: (b)(6) 2017 ; right hip.
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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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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 caused or contributed to the potential event described in this report.H10 additional narrative: udi: (b)(4).Added: a2(dob), b5, b7, d1, d2, d2b, d4(product and lot number, expiration date and udi), d6, g5, h4 and h6 (patient).Corrected: a1, a2(age).No code available use for medical device removal and surgical intervention.
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Event Description
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After review of medical records patient was revised to addressed pain in prosthetic joint, sequela, metal on metal hip arthroplasty with metallosis.Operative report indicated thick dark fluid consistent with metallosis, a lot of devitalized tissue circumferential around the hip joint.Added law firm, lawyer, date of birth, medical history, date of implant and product details of liner and head in impacted products.Corrected patient's initial and age of patient.Doi: (b)(6) 2007 dor: (b)(6)2017 right hip.Cn(wipro).
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Manufacturer Narrative
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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.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: null.Device history batch: null.Device history review: null.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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Search Alerts/Recalls
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