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

Model Number	300-01-09
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical device(s): (b)(4) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(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) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4) 320-31-36 - glenosphere, 36mm.(b)(4) 320-35-03 - small posterior augment glenoid plate, left.(b)(4) 320-36-03 - 36mm humeral liner +2.5mm unconstrained.(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 - shouldr gps hex pins kit.(b)(4) a10012 - gps implant kit v2.
Event or Problem Description
As reported, this 65 year old female patient had an initial right tsa on (b)(6) 2022.The patient was revised on (b)(6) 2023 due to dislocation.The initial dislocation was relocated on (b)(6) 2023, however, overnight the patient re-dislocated again.The plan initially was to upsize the humeral liner/tray, however, once open, when attempting to disengage the torque screw, the humeral stem became loose.A new 9mm stem was cemented in-situ and trialed off where a +5mm tray and +2.5 36mm constrained humeral liner was 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
H3: upon review, there is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.Corrections: d1, d2a, d2b, d4, g4, h4.

• Brand Name: EQUINOXE REVERSE SHOULDER SYSTEM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 16292908
• Report Number: 1038671-2023-00097
• Device Sequence Number: 6255149
• Product Code: KWS
• UDI-Device Identifier: 10885862086624
• UDI-Public: 10885862086624
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093275
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 03/30/2025
• Device Model Number: 300-01-09
• Device Catalogue Number: 320-36-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 11/11/2025
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/28/2023; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female