Catalog Number 151640805 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 09/18/2019 |
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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Occupation: lawyer.(b)(4).
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Event Description
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Attune litigation record received.Litigation record alleges severe and persistent pain, discomfort, instability, difficulty ambulating, swelling and aseptic loosening tibial tray at the cement to implant interface.Unknown cement was used.Doi: (b)(6) 2016, dor: (b)(6) 2020, left knee.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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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On (b)(6) 2016, the patient had a primary left total knee arthroplasty to address degenerative joint disease.Depuy components, including depuy patella were used during this procedure.On (b)(6) 2017 the patient had an aspiration and injection in his left knee to address persistent pain, soreness, and swelling.On (b)(6) 2019, the patient had a revision of the arthroplasty to address failed left total knee revision with tibial loosening, no interface provided.Femoral component was noted to be well fixed.Medical records noted that prior to surgery the patient was experiencing pain and swelling.Depuy components, including depuy cement were used during this procedure.
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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.Udi : (b)(4).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).3500a h10 cross reference for (b)(4), this device was also subject of (b)(4), as the patient experienced adverse events on different days with the same device.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.
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Search Alerts/Recalls
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