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

Model Number	320-01-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Medical device site infection (4845)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2022.The patient was revised on (b)(6) 2023, due to periprosthetic joint infection.A cement spacer was inserted to treat the infection.There was no reported breakage of 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), 300-01-09, equinoxe, humeral stem primary, press fit 9mm (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), 320-20-18, eq rev compress screw lck cap kit, 4.5 x 18mm, (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), 320-38-03, equinoxe reverse 38mm humeral liner +2.5, (b)(4), 321-52-10, 3.2mm k-wire, thd, short 2 k-wires per pack, (b)(4), 531-55-88, ergo gps 3.2mm drill kit sterile, (b)(4), 531-78-20, shoulder gps hex pins kit 1000222019, (b)(4), gps implant kit v2.
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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Event or Problem Description
As reported, the patient had an initial left tsa.The patient was revised due to periprosthetic joint infection.A cement spacer was inserted to treat the infection.There was no reported breakage of 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
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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient's underlying condition.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4 (remove expiration date) d8, g1, g4, f10 (remove data from initial) h4 (remove manufactured date), h6: annex b, d, e, f.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17265636
• Report Number: 1038671-2023-01557
• Device Sequence Number: 15469340
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 02/18/2026

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: 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: 06/16/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 02/07/2026
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 12/05/2023; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male