EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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Sectiond10: concomitant products.Eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Equinoxe, humeral stem primary, press fit 15mm (cat# 300-01-15 / (b)(6)).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / (b)(6)).Rs glenoid plate post aug, 8 deg, left (cat# 320-15-03 / (b)(6)).Equinoxe reverse 42mm glenosphere (cat# 320-01-42 / (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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As reported, approximately six months post initial left tsa, the 75 y/o male patient was revised due to infection.All components were removed and an antibiotic spacer was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to the implants were discarded.
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Manufacturer Narrative
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As reported, approximately six months post initial left tsa, the 75 y/o male patient was revised due to infection.All components were removed, and an antibiotic spacer was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Based on the available information, the device appears to elicit undesired physical response in the patient without inherent device failure.Furthermore, an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.
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Search Alerts/Recalls
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