SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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Model Number 74022213 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka surgery, a journey ii bcs xlpe art isrt size 3-4-rt 15 mm ((b)(4)) was not able to be fully seat into journey tibia baseplate np rt sz 3 ((b)(4)), a 0.5 mm gap between the baseplate was left and two dents on anterior side of insert were deformed by inserter.Surgery was completed with the same devices because there was no spare devices available.This problem caused a less than 30 min surgery delay.Patient was reported to be harmed but it is unknown how.
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Manufacturer Narrative
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H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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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