SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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Model Number 71453212 |
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 05/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during tka surgery, a legion ps high flex xlpe size 3-4 11mm did not match with the baseplate.Surgery was completed with a back-up device of the same size.It is unknown if this caused any delay in the surgery.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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G3, h2,h3 and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned insert confirms minor damage, more than likely from attempted insertion.The legion ps high flex xlpe is damaged around the base and lock, therefore making it difficult to mate with the baseplate.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 do not have 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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