SMITH & NEPHEW, INC. VISIONAIRE CUT GUIDE INSTR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number UNKNOWN |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Laceration(s) (1946)
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Event Date 05/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: internal complaint reference: case(b)(4).
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Event Description
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It was reported that during a left tka surgery, the surgeon had to take an additional +2 from the distal, +2 from the tibia, as well as downsize, since the vis adpt guide kit jii device was a bad fit.The procedure was resumed, after a non-significant delay, with a manual instruments.No further complications were reported.
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Manufacturer Narrative
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This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and 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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