STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5531-G-613 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/02/2020 |
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Primary procedure, left knee.It was reported that the insert would not seat into the baseplate.A 2nd implant of the same lot code was opened and seated, but additional effort than normal was required.Procedure completed successfully with no delay.The wasted insert is allegedly available for return.Rep confirmed that no further information will be available.
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Search Alerts/Recalls
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