MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/08/2024

Event Type  Injury  

Event Description

It was reported that an 86 yo female patient, initial right reverse total shoulder implanted on (b)(6) 2013, underwent a revision procedure on (b)(6) 2024, approximately 10 years 4 months post the initial procedure.The patient returned to the surgeon¿s office reporting right shoulder pain, discomfort, and decreased motion.Initial x-rays showed potential loosening of components and inferior scapular notching.The patient decided to wait and watch their shoulder but then became dislocated.Upon returning to the surgeon¿s office with a dislocated prosthesis, she was booked for a right revision of her reverse tsa implantation of bone graft and an antibiotic spacer.They planned to return and reimplant a prosthesis after bone grafting was intended.On (b)(6) 2024 the patient underwent revision shoulder surgery.Upon opening the wound the surgeon noted substantial metalosis.The liner was still attached to the tray and humeral stem, though the entire construct was dislocated and not in a good position and it pulled out of the humerus by hand with little force.The cement was cleaned and cleared from the humeral bone as best as possible.There was further proximal bone loss after removal.Then the glenosphere screw was removed, the glenosphere popped off of the baseplate.Cultures were taken during the procedure.Initial stat cultures came back negative.The patient needs bone graft behind the glenoid.The locking caps and screws were removed from the baseplate.There was one screw in the anterior superior hole of the baseplate that would not loosen from the baseplate with the standard 3.5 hex driver.A synthesis broken screw removal set was opened and a conical bit was used to backout the problem screw.Once all screws were removed the baseplate was removed from the glenoid bone.The wound was cleaned, debrided, and irrigated well.Bone graft was applied to the glenoid and a competitor¿s antibiotic pre-molded shoulder spacer was implanted.The plan is to return in 2-3 months for a revision reimplantation of a stable reverse implant.The reported event is not related to a breakage of device.The event led to 5 -15-minute surgical prolongation.The patient did not experience any adverse events as a result of the prolongation and was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for return as they were discarded by the hospital.Device images were provided.No further information.

Manufacturer Narrative

D10: concomitants: (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-10-10 - equinoxe reverse tray adapter plate tray +10.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.(b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19073940
• MDR Text Key: 339777266
• Report Number: 1038671-2024-00767
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2022
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Date Device Manufactured: 11/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female