SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71422436 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Injury (2348)
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Event Date 10/08/2018 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to implant malfunction.Insert and tibial tray explanted.Back up available.
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Manufacturer Narrative
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The affected journey uni tibial insert and journey uni tibial baseplate were not returned for evaluation.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.Should additional information be received, the complaint will be reopened.
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