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 Problems
Break (1069); Material Separation (1562)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2020 |
Event Type
malfunction
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Event Description
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It was reported that during tka surgery, when using the journey ii cr lkg fem imp bumper right as a secondary, the device cracked in two pieces during impaction internal to patient.No pieces went into the surgical site.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.
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Manufacturer Narrative
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G4, h2, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.H6: clinical, impact, medical device problem and component code updated.
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