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

Model Number	GLENOSPHERE, 36MM
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: equinoxe, humeral stem primary, press fit 11mm (cat# 300-01-11 / serial# (b)(4), equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(4), eq rev locking screw (cat# 320-15-05 / serial# (b)(4), eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4), eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(4), eq rev compress screw lck cap kit, 4.5 x 26mm (cat# 320-20-26 / serial# (b)(4), small posterior augment glenoid plate, left (cat# 320-35-03 / serial# (b)(4), 36mm humeral liner +0 unconstrained (cat# 320-36-00 / serial# (b)(4), equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(4).As reported by the equinoxe shoulder study, approximately three years post initial tsa, the 71 y/o female patient was sitting on her couch when her shoulder dislocated while trying to stand up.Patient had a revision on (b)(6) 2022 for a standard reverse.Per clinical study case report the event is definitely related to the device and to the procedure.No additional information.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 shoulder dislocation cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately three years post initial tsa, the 71 y/o female patient was sitting on her couch when her shoulder dislocated while trying to stand up.Patient had a revision on (b)(6) 2022 for a standard reverse.Per clinical study case report the event is definitely related to the device and to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from the initial report-suspect device unknown) g4 (remove 501k from the initial report-unknown) h6: medical device problem code, component code and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUIONXE REVERSE SHOULDER SYSTEM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15657998
• Report Number: 1038671-2022-01344
• Device Sequence Number: 6436016
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 10/05/2022
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White