SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Model Number 74012414 |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
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 prior to tka procedure, during set up inspection process, the journey dcf ap femoral cutting block, size 4, was found with contamination inside the block, chemicals remaining around middle part of block.Multiple methods of sterilization trialed.There was no case involved.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.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 and assessed for any necessary corrective actions.Some potential probable causes for this event could include inadequate cleaning or over exposure to contaminates.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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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