Model Number 1024-07-400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).(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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It was reported that the patient had clicking and some pain over time.The surgeon performed an arthroscopy in the past and noticed the uni poly was lifting up in the front and he was concerned that it could be causing discomfort to the patient.The surgeon would like a letter back to him responding to what was causing the poly to be lifting up.He was wondering if the poly was out of spec.To the tray that was originally implanted.Doi: (b)(6) 2016.Dor: (b)(6) 2019.Left knee.
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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).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : null.Device history batch : null.Device history review : null.
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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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Medical records reviewed.On (b)(6) 2016, patient received a medial left knee unicompartmental arthroplasty, to address medial compartment osteoarthritis.There was no reported complication.On (b)(6) 2018, patient's left knee was revised to address pain and suspected implant loosening.It was determined though, that there was no implant loosening--both femur and tibial tray components were well-fixed.Rather, it was identified that the tibial insert component locking mechanism had partially failed, with the insert moving in the tray.This insert component was revised, and scar tissue excised.
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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 complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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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Search Alerts/Recalls
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