STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5531-G-309 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 09/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been three other events for the lot referenced.The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510f301; lot# enp7e; triathlon asymmetric x3 patella; cat# 5551-g-320; lot# xj4t; triathlon prim tib baseplate - cemented; cat# 5520-b-300; lot# bxt3ha.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
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Event Description
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Patient had a left knee aspiration 15ml bloody synovial fluid on (b)(6) 2019 after complaint of pain, stiffness, and effusion.
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