SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74027281 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka, a journey tibia base np lt sz 7 did not seat into tibia base.Surgery was resumed, without any significant delay, with an available smith and nephew back up device; therefore, patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned insert confirms damage to the lock detail, more than likely from attempting to snap into the tibial base.The visual also confirms some scratches on the surface of the insert.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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