STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5537-G-619 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Surgeon reported that the triathlon ts 19 mm insert wouldn¿t sit correctly in universal base plate.He further reported that he then inserted the ts 16 mm insert into the universal base tibial base plate, again this didn¿t seat properly, he impacted the liner again and inserted the post and said that he would bring patient back to theatre next day for a liner exchange.There was a 10 minute delay to surgery.
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