STRYKER ORTHOPAEDICS-MAHWAH MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180737-1 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.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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X3 onlay tibial insert did not lock into tibial baseplate.Locking mechanism was compromised with repeated attempts to properly seat, and insert was subsequently discarded.Second tibial insert was opened, and was properly seated without difficulty.
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Search Alerts/Recalls
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