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

Model Number EQUINOXE REVERSE 42MM GLENOSPHERE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Laxity (4526)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported a 73 yo male patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 6 months post the initial procedure.The patient was revised due to a dislocation.The adaptor tray, liner, and glenoshpere were revised.There were no device breakages or surgical delays during the procedure.The rep was unable to obtain x-rays or device images.The patient was last known to be in stable condition following the event.No device returns for analysis anticipated due to the hospital disposed of them.No further information.

Manufacturer Narrative

D10: concomitants: (b)(6) - 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6) - 315-35-00 - glnd kwire, (b)(6) - 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6) - 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6) - 320-15-04 - rs glenoid plate post aug, 8 deg, right, (b)(6) - 320-15-05 - eq rev locking screw, (b)(6) - 320-20-00 - eq reverse torque defining screw kit, (b)(6) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6) - 320-42-00 - equinoxe reverse 42mm humeral liner +0, (b)(6) - 531-55-88 - ergo gps 3.2mm drill kit sterile, (b)(6) - 531-78-20 - shouldr gps hex pins kit, (b)(6) - 531-78-20 - shouldr gps hex pins kit, 2029223091 (b)(6) - gps implant kit v2, additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

The glenosphere, liner and adapter tray were appropriately released for distribution.The reason for the patient's dislocation and subsequent revision procedure as related to the devices cannot be conclusively determined.There was no medical or clinical information provided.These devices are used for treatment not diagnosis.

• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18735697
• MDR Text Key: 335733975
• Report Number: 1038671-2024-00259
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male