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

Model Number	320-36-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Muscle/Tendon Damage (4532); Bursitis (4832)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 9 months post op the initial reverse tsa, this 83 y/o female patient developed pain over the last two weeks.Whenever she got in and out of van, she had to pull herself up to the seats using the right hand multiple times.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.Action taken: apply ice and heat packs.The outcome is continuing.No additional information.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition [pulling with her arm on the replacement side] that impacts the performance of the device.It is well known that excessive activity and trauma affect joint replacements.Concomitant medical products: 300-01-10 - equinoxe humeral stem primary press fit 10mm, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-31-36 - glenosphere, 36mm, 320-35-01 - small glenoid plate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4(remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h6: clinical codes, impact code, type of investigation and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 16029002
• Report Number: 1038671-2022-01619
• Device Sequence Number: 12173034
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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?: No
• Operator of Device: Health Professional
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 38 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White