MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-30-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 320-38-00 - equinoxe reverse 38mm humeral liner +0: 5379926.320-10-00 - equinoxe reverse tray adapter plate tray +0: 5675956.320-01-38 - equinoxe reverse 38mm glenosphere: 5680089.320-15-01 - eq rev glenoid plate: 5617118.
Event or Problem Description
Study: equinoxe shoulder study.Subject: (b)(6).As reported by the equinoxe shoulder study, the patient had an initial right tsa on (b)(6)2018 and presented on and unknown date in 2021 with pain - unexplained; superior shoulder pain without evidence of fracture.Increased pain without injury during the summer of 2021.The case report form indicates that this event is definitely not related to the device and/or to the procedure.Patient advised to take action of immobilization for 6 weeks.The outcome of this event is resolved on 14-jun-2022.Height: 63 in / bmi: 26.Previous surgery on involved shoulder? yes, on (b)(6) 2008; rotator cuff repair.Diagnosis: rotator cuff tear.Other diagnosis: functional pseudoparalysis.Comorbidities: hypothyroidism.300-30-08 - equinoxe preserve stem 8mm: 5569575.510k: k162726.No device return anticipated due to being a clinical trial study.
Additional Manufacturer Narrative
The reason for the pain reported cannot be conclusively determined but may be related to an underlying patient condition, infection, component loosening, component sizing, positioning, or impingement issues, or a combination of the above.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.D1: corrected d4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18481214
• Report Number: 1038671-2024-00062
• Device Sequence Number: 20446980
• Product Code: HSD
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Catalogue Number: 300-30-08
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2018
• 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.
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White