STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5521-B-500 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/26/2018 |
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 lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.
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Manufacturer Narrative
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An event regarding seating/locking issues involving a triathlon baseplate was reported.The event was not confirmed.Conclusions: the reported event is not confirmed.The returned device was found to be within specifications dimensionally and functionally.See attached inspection report.Discussion with marketing and product support engineering group assessed both devices and found the devices to be functionally acceptable.If additional information becomes available, this investigation will be reopened.
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Event Description
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Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.
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Search Alerts/Recalls
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