STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5536-B-300 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/31/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient's right knee was revised due to subsidence of the tibial baseplate (possible cause or contributor for subsidence not reported to rep).A baseplate and poly insert were revised to a baseplate, stem, and poly insert.
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Manufacturer Narrative
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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.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.
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Search Alerts/Recalls
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