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

Model Number	320-36-00
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that this patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.
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 the shoulder revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.(d10) concomitant device(s): 300-01-12, (b)(6)- equinoxe humeral stem primary press fit 12mm, 320-10-10, (b)(6)- equinoxe reverse tray adapter plate tray +10, 320-15-05, (b)(6)- eq rev locking screw, 320-20-00, (b)(6)- eq reverse torque defining screw kit, 320-20-18, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 18mm, 320-20-26, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-26, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 26mm, 320-31-36, (b)(6)- glenosphere, 36mm.320-35-02, (b)(6)- small superior augment glenoid plate section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that this female patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.There were no reported issues during the revision surgical procedure.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.Multiple attempts have been made for additional information/ no responses have been received.(d1) brand name: 36mm humeral liner +0 unconstrained (d4) catalog number: 320-36-00, serial number: (b)(6), expiration date: 24-jun-2024, unique identifier (udi) #: (b)(4).(h4) device manufacture date: 28-jun-2019.
Event or Problem Description
It was reported that this female patient's left shoulder was revised and an antibiotic spacer was inserted.All reverse shoulder parts were explanted.There were no reported issues during the revision surgical procedure.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.Multiple attempts have been made for additional information/ no responses have been received.
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 follow up #1 report suspect device unknown), d8, h4 (remove erroneously entered date from the follow #1 report-unknown), h6: health effect clinical code, health effect- impact code, medical device problem code and investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15536367
• Report Number: 1038671-2022-01226
• Device Sequence Number: 8133490
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 02/21/2026

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: 06/24/2024
• Device Model Number: 320-36-00
• Device Catalogue Number: 320-36-00
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 02/14/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/23/2022; 02/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female