SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71422255 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during ukr, the journey uni tibinrt s3-4rm/ll8mm did not lock into the tibial baseplate as expected.The surgeon tried for many attempts but, the device was not able to lock it in place.A back-up insert from smith and nephew was opened, and it locked in place at first try.A surgical delay of less than or equal to 30 minutes was reported.No patient injury or other complications were reported.
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Manufacturer Narrative
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H3, 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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