SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71422261 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/13/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient suffered from a postoperative infection.The customer requirement is to check the lot regarding sterility.No more information presented.
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Manufacturer Narrative
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The associated journey uni tibial insert, journey uni cocr femoral component and journey uni tibial baseplate were not returned for evaluation.Our clinical analysis noted that no lab results or reports were provided to confirm the reported infection.Therefore a thorough medical assessment cannot be completed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Products were sterilized according to sterilization release documentation from quality control.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products 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.Should the devices or additional information be received, the complaint will be reopened.
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