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

Model Number	300-01-09
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 77 year old female patient presented with posterior dislocation of the humerus, and pain.The surgeon opened the joint to find frank pus.The patient was revised on (b)(6) 2023; all components were removed and a spacer placed in-situ.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: (b)(4): 315-35-00 - glnd kwire.(b)(4): 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(4): 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4): 320-15-01 - eq rev glenoid plate.(b)(4): 320-15-05 - eq rev locking screw.(b)(4): 320-20-00 - eq reverse torque defining screw kit.(b)(4): 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4): 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(4): 321-20-00 - equinoxe reverse shoulder drill kit.
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 dislocation, infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• 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: 16740126
• Report Number: 1038671-2023-00687
• Device Sequence Number: 17858054
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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 Model Number: 300-01-09
• Device Catalogue Number: 300-01-09
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 05/11/2026
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/29/2023; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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 Age: 78 YR
• Patient Sex: Female