Model Number 108400 |
Device Problems
No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
Injury
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Event Description
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After case was completed successfully, ct noticed the next patient's case report (tplan pdf) was hung up on the wall of or and discussed prior to this surgery.Discussion was regarding resection values and implant size with ct's, djo rep and the surgeon.This case was planned for a size 6 femur and size 6 tibia.The surgeon inserted size 7 femur and size 7 tibia as stated on the next patient's tplan pdf, and after size 7 trials were tested.Ct informed the surgeon of the issue.The surgeon was pleased with the fit, and felt comfortable with the outcome, and recognized it is the surgeon preference on implant choice.Once post-operative x-ray was available the surgeon reviewed with ct's and confirmed the implant fit was good.
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Manufacturer Narrative
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No patient injury reported.However, it was reported that size 7 femur and size 7 tibia was used instead of size 6 femur and size 6 tibia.The issue occurred because a pdf of the case plan for the second case (size 7 femur and size 7 tibia) was posted on the or wall for reference and that was what the surgeon and clinical staff used to determine which implant was approved as part of the case plan instead of the system verification screen.During the preparation, the tsolution one operated within nominal specifications.The pdf was consulted, and the size 7 implants were implanted after trialing and floating the knee to set rotation.No gap between the prepared bone and the implant was observed intraoperatively or on post-operative xray.The surgeon confirmed, the implant fit was good, and there was no harm to the patient.
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Search Alerts/Recalls
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