SMITH & NEPHEW, INC. JRN II BCS LCK FEM IMPLANT IMPACT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 74012812 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2021 |
Event Type
malfunction
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Event Description
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It was reported that a journey femoral implant impactor bumper left (case (b)(4)) was found broken in half, and a journey ii bcs locking femoral implant impactor (case (b)(4)) is starting to chip.As this was noticed in a non-surgical environment, there was not any patient involved.
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Manufacturer Narrative
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G3, h2, h3, and h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no 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.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.G4: add 510k code.
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