STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-G-611 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Injury (2348)
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Event Date 09/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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The following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-391; lot# dp6dr.Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# jauba.Triathlon ps fem component, cemented; cat# 5515-f-502; lot# jgzta.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the product history records indicates the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
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Event Description
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It was reported through the filing of a lawsuit that the patient underwent a right total knee revision on (b)(6) 2015.It is further alleged that the patient underwent a second revision on (b)(6) 2016 due to "wrong sized componentry".
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Search Alerts/Recalls
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