SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71453111 |
Device Problems
Connection Problem (2900); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka, the medial dovetail mechanism was bent on the distal portion of lgn cr high flex xlpe sz 3-4 9mm was bent causing an obstruction.The device did not seat or lock into place.Procedure was performed, without any delay, by using a back-up device.Patient was not impacted by this event.
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Manufacturer Narrative
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H6ñ the device, used in treatment, was returned for evaluation.A visual inspection of the returned insert confirms damage to the lock detail, more than likely from attempting to snap into the baseplate.The visual also confirms some scratches on the surface of the insert.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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