SMITH & NEPHEW, INC. JRNY II CR LKG FEM IMP BUMPER RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74011857 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2021 |
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 a journey ii cr lkg fem imp bumper right is cracked.It remains unknown when this problem was noticed/occurred and if a patient was involved.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned jrny ii cr lkg fem imp bumper rt confirmed the device is broken in half and both pieces were returned.This device also has extensive wear usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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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