EXACTECH, INC. EQUINOXE CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number EQUINOXE CAGE GLENOID SMALL, ALPHA |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/07/2024 |
Event Type
Injury
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Event Description
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As reported, the 64 year old female patient had an initial right tsa on (b)(6) 2020.The patient was revised on (b)(6) 2024 due to poly failure.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays received.The devices are not available for evaluation due to chain of command.
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Manufacturer Narrative
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Section d10: concomitant products: - equinoxe, humeral stem primary, press fit 9mm (cat# 300-01-09 / serial# (b)(6)).- equinoxe replicator plate 4.5mm o/s (cat# 00-10-45 / serial# (b)(6)).- equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6)).- equinoxe, humeral head short, 38mm (alpha) (cat# 310-01-38 / serial# (b)(6)).- equinoxe cage glenoid small, alpha (cat# 314-13-02 / serial# (b)(6)).- glnd kwire (cat# 315-35-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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