EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
|
Back to Search Results |
|
Model Number SHOULDER IMPLANT |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2023 |
Event Type
malfunction
|
Event Description
|
As reported by the equinoxe shoulder study, approximately one year post initial tsa, the 69 y/o male patient had broken screw identified on x-ray.The event was resolved.Patient is doing well.Patient is asymptomatic.No action taken.Per clinical report, the reported event is definitely not related to the device and unlikely related to the procedure.
|
|
Manufacturer Narrative
|
Section d10: concomitant products; reverse humeral liner (cat# 320-42-00 / serial# (b)(6), reverse humeral tray (cat# 320-10-00 / serial# (b)(6), reverse glenosphere baseplate (cat# 320-15-06 / serial# (b)(6), equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
|
|
Search Alerts/Recalls
|
|
|