SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 2; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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Catalog Number 74022222 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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Event Date 09/03/2019 |
Event Type
malfunction
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Event Description
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It was reported that after the implantation, a foreign particle was found, and it was picked up from the patient body.It was unknown if the particle was caused by the instruments or implants.
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Manufacturer Narrative
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The associated complaint devices were not returned.The particle associated with this complaint was returned and evaluated.The material analysis concluded that the metallic particle was a titanium alloy, which is consistent with the material used to manufacture the tibial base.The origin of the particle could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Credit cannot be issued for the devices.
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