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

Catalog Number	320-15-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): - equinoxe preserve stem 12mm (cat# 300-30-12 / serial# (b)(6)).- 145-deg pe 38mm hum liner +0 (cat# 320-38-00 / serial# (b)(6)).- equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)).- glenosphere 38mm (cat# 320-06-38 / serial# (b)(6)).
Event or Problem Description
As reported by the equinoxe shoulder study, approximately two years post initial right tsa, the 55 y/o female patient experienced stiff shoulder.After shoulder replacement, patient underwent a tendon transfer to address chronic scapular dyskinesis and struggled with stiffness and pain following this procedure thought to be related to excessive scar tissue adhesions.Per clinical report, the reported event is definitely not related to the device and unlikely related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11 the following sections were corrected: d1, d4, g4, h4, h6 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an underlying patient condition, infection, component loosening, component sizing, positioning, or impingement issues, scar tissue adhesions, or a combination of the above.It remains unclear whether the previous tendon transfer procedures played a contributing factor to the reported scar tissue adhesions however, this cannot be confirmed because the devices remain implanted, and relevant images, or radiographs were not provided.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 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19571248
• Report Number: 1038671-2024-02029
• Device Sequence Number: 18265981
• Product Code: KWT
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 05/08/2026

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 Catalogue Number: 320-15-08
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White