EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number 300-01-09 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder revision cannot be conclusively determined; however, it is most likely due to patient related conditions associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition, such as poor bone quality, that impacts the performance of the device.Concomitant device(s): equinoxe replicator plate 1.5mm o/s - 300-10-15, 6443382.Equinox square define screw drive kit - 300-20-02, 6536242.Equinoxe, humeral short, 41mm (alpha) - 310-01-41, 6760537.
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Event Description
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As reported, approximately 2 months post op of a left tsa, this 63 y/o male patient was revised to a reverse shoulder with graft."the graft hadn¿t previously taken from the previous revision (, the patient had poor bone." there was no reported issues during the revision surgical procedure.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.Devices will not be returning, disposed of by hospital.No other information is available.Please reference (b)(4) for previous revision.
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Search Alerts/Recalls
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