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

Model Number	320-01-38
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2018.The patient was revised on (b)(6) 2023 due to repeat dislocations.New reverse components were implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.D10: 5143706 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.5048172 315-35-00 - glnd kwire.5048206 315-35-00 - glnd kwire.5201214 315-35-00 - glnd kwire.3909106 320-10-05 - equinoxe reverse tray adapter plate tray +5.4838417 320-15-03 - rs glenoid plate post aug, 8 deg, left.5158524 320-15-05 - eq rev locking screw.5140945 320-20-00 - eq reverse torque defining screw kit.5103634 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.5190833 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.5011600 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.5171651 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.3874478 320-38-10 - equinoxe reverse 38mm humeral const liner +0.5175206 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
H3: upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2, b1, b2, d1, d4 (remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown) h4 (remove erroneous date from initial report), h6: clinical code, types, findings and conclusion of investigation codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.Based on review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17322286
• Report Number: 1038671-2023-01659
• Device Sequence Number: 6347365
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 320-01-38
• Device Catalogue Number: 320-01-38
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 12/08/2025
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 12/15/2023; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• 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; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male