SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71453211 |
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 06/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a tka the legion ps high flex xlpe size 3-4 9mm will not seat on the baseplate.Surgery continued with a back up device, no delay reported.Patient was not harmed as a consequence.
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Manufacturer Narrative
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H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.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.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.Should 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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