SMITH & NEPHEW, INC. JOURNEY INSTR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/27/2020 |
Event Type
Injury
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Event Description
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It was reported that during tka procedure the plastic part of the jrny uni tibial impactor, journey fem impl impactor and a third impactor (unknown part) broke while being used inside the patient.There was no delay.Procedure concluded with the same device.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that only the uni tibia impactor, failed during the surgery, the other items are not presenting any malfunction nor caused any adverse event to report, therefore, it was determined that this case does not meet the threshold for reporting and complaint criteria, this is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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