SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 13MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71423354 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during tkr surgery, surgeon was unable to align the screw with the legion hk gd motion isrt 13 mm sz 4-5 lt and the legion hk tibial base sz 5 lt for a successful insertion.Surgery was resumed, after a 40 minutes delay, with the same devices.It is unknown the current health status of the patient.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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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Search Alerts/Recalls
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