SMITH & NEPHEW, INC. VIS ADPT GUIDE KIT JII; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number V0100112 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2021 |
Event Type
Injury
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Event Description
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It was reported that during tka surgery the doctor pinned the visionaire femoral guide into place and made his distal femoral cut.When he put the size 4 planned size cutting guide into the pre drilled holes it seemed to have put them into extreme external rotation and would have taken off and estimated 15+ mm of bone off the posterior medial side.He then decided to change to conventional instrumentation and sized the femoral to a size 5 and the rotation was put correctly to 3 degrees of external rotation.They then used the visionaire tibial cutting guide and seemed to line up correctly and made the resection.When they checked the pre drilled tibial rotation, it again was extremely externally rotated.We then corrected that inter-op and sized it up one size from a 2 to a 3.Patient was not harmed as consequence of this problem.It is unknown if there was a surgical delay.
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Manufacturer Narrative
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After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during tka surgery, the doctor pinned the visionaire femoral guide into place and made his distal femoral cut.When he put the size 4 planned size cutting guide into the pre-drilled holes it seemed to have put them into extreme external rotation and would have taken off and estimated 15+ mm of bone off the posterior medial side.He then decided to change to conventional instrumentation and sized the femoral to a size 5 and the rotation was put correctly to 3 degrees of external rotation.They then used the visionaire tibial cutting guide and seemed to line up correctly and made the resection.When they checked the pre-drilled tibial rotation, it again was extremely externally rotated.We then corrected that inter-op and sized it up one size from a 2 to a 3.The procedure was completed with a delay of less than 30 minutes.Patient was not harmed as consequence of this malfunction.However, after further clarification and information received, it was determined that the present complaint does not meet the criteria to be reportable nor to be a complaint, because the two devices involved: the femoral and the tibial cutting blocks, are included in the vis cut guide jbcs kit rt.Therefore, the report already submitted (report number: 1020279-2021-05537) covers the malfunction of both devices.
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