SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, POLY/METAL/POLY
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Catalog Number UNKN01200302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cellulitis (1768)
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Event Date 05/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
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Event Description
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It was reported that on literature review "imageless robotic-assisted total knee arthroplasty leads to similar 24-month womac scores as compared to conventional total knee arthroplasty: a retrospective cohort study", 7 patients suffered from a superficial surgical site complication (cellulitis), after having a primary total knee arthroplasty.The aforementioned primary surgery was robotically assisted with navio.The infections had evidence on physical exam and were treated with antibiotics.The current state of health of the patients is unknown.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, in a literature review that 7 patients suffered from a superficial surgical site complication (cellulitis), after having a primary total knee arthroplasty.The primary surgery was robotically assisted with navio.The infections were treated with antibiotics.No further information is available.Without clinical and patient specific information, a thorough clinical/medical investigation cannot be performed.The patients¿ outcomes/impacts beyond that which was documented in the article cannot be confirmed nor concluded.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to loss of sterility, contamination, patient reaction, and post-operative healing issue.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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