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

Model Number	GLENOSPHERE, 36MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: serial #: (b)(4), category #: 531-78-20 - shoulder gps hex pins kit, serial #: (b)(4), category #: 308-01-08 - 8x80mm distal stem modular cemented, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, serial #: (b)(4), category #: 308-10-00 - med prox body +0, serial #: (b)(4), category #: 300-21-00 - 0mm fixed angled kit, serial #: (b)(4), category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), category #: 320-36-03 - 145-deg pe 36mm hum liner +2.5, serial #: (b)(4), category #: 320-15-05 - eq rev locking screw, serial #: (b)(4), category #: 315-35-00 - glnd kwire, serial #: (b)(4), category #: 320-35-01 - small glenoid plate, serial #: (b)(4), category #: 308-05-22 - distal fixation ring ha 22.5, serial #: (b)(4), category #: 308-15-01 - taper locking screw 0, serial #: (b)(4), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category #: 320-20-00 - eq reverse torque defining screw kit, serial #: (b)(4), category #: tpa-13 - cement restrictor xs (extra small, sz 13), serial #: (b)(4), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 61 yo female patient, initial right shoulder implanted on (b)(6) 2023, was revised on (b)(6) 2023.The reason for the revision was not reported.There was a less than 30 second delay during the procedure with no patient impact as a result.The patient was last known to be in stable condition following the event.No further information.
Event or Problem Description
No implants were broken during implantation , in situ, or explantation.Patient was revised to an expanded glenosphere and constrained poly due to laxity that was discovered during post op visit.No implants are available to send back.
Event or Problem Description
Patient revised due to instability.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d4 (remove all from initial report-suspect product unknown), g4 (remove from initial report - 501k unknown), h4 (remove erroneous date form initial report), h6 medical device problem code, component code, type of investigation, investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENT
• Common Device Name: 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: kate jacobson ; 3523771140
• MDR Report Key: 16668415
• Report Number: 1038671-2023-00570
• Device Sequence Number: 6521536
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/16/2023; 10/09/2025
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 08/16/2023; 08/16/2023; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female