MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-01-42
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Limb Fracture (4518)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7 years post op the initial tsa, this patient's right shoulder was revised due to dislocation and scapular spine fracture.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm sn: (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0 sn: (b)(4), 320-15-01 - eq rev glenoid plate sn: (b)(4), 320-15-05 - eq rev locking screw sn: (b)(4), 320-20-00 - eq reverse torque defining screw kit sn: (b)(4), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm sn: (b)(4), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm sn: (b)(4), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm sn: (b)(4), 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm sn: (b)(4), 320-42-00 - equinoxe reverse 42mm humeral liner +0 sn: (b)(4).
Additional Manufacturer Narrative
Section h10: (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 surgical revision due to dislocation cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Scapular spine fractures after reverse total shoulder arthroplasty occur predominantly as a result of bony insufficiency.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 7 years post op the reverse tsa, this patient's right shoulder was revised due to dislocation and scapular spine fracture.There were no reported issues during the revision surgical procedure.Devices will not be returned per hospital policy.The patient was last known to be in stable condition following the event.Patient demographic information is reported as unknown.No additional information.
Event or Problem Description
As reported, approximately 7 years post op the reverse tsa, this patient's right shoulder was revised due to dislocation and scapular spine fracture.There were no reported issues during the revision surgical procedure.Devices will not be returned per hospital policy.The patient was last known to be in stable condition following the event.Patient demographic information is reported as unknown.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6.The following sections were corrected: h6.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15391073
• Report Number: 1038671-2022-01072
• Device Sequence Number: 17439055
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2025
• Device Model Number: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 04/16/2026
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/09/2022; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown