SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71422251 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
Event Type
Injury
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Event Description
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It was reported that during a ukr, the journey uni tibinrt s3-4lm/rl8mm was wrongly packed causing it to be used to implantation with a journey ii tibial base.Surgeon spent 10-15 min trying to put it in, until realized it was a journey i insert.No back-up device was available, so a journey ii uni tib xlpe ins sz 3-4 9mm lm/rl was implanted.A 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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The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the failure mode was confirmed.The clinical medical evaluation concluded that, based on the returned product packaging and complaint details, the j-uni insert was used in an unsuccessful implantation attempt with a jii-uni tibial baseplate due to human error.It is the o.R.Staff and surgeon responsibility to ensure that correct and compatible implants are available prior to the surgical procedure.The assessed patient impact was the surgical delay, although no patient harm or further complications were reported.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is a user error.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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