STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G411 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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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It was reported that, during a tka, after locking the insert, a surgeon noticed a gap(1mm lateral/posterior) between the inset and baseplate.Therefore, he tried to insert another size insert but it was also same condition.The second stayed implanted.Update: the delay time was about 2-3 minutes.Right side.
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