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

Catalog Number	300-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Inflammation (1932); Implant Pain (4561)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-10-10 - equinoxe reverse tray adapter plate tray +10: 5232147.320-02-42 - rs expanded glenosphere 42mm, +4mm offset: 5645362.320-15-05 - eq rev locking screw: 5600768.320-20-00 - eq reverse torque defining screw kit: 5667604.(h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had a left tsa on (b)(6) 2019 and presented with deep infection, on (b)(6) 2022.Patient was seen on (b)(6) 2022.Describes significant pain shoulder while attempting to lift a 50lbs.Bag 6 weeks prior to visit.Work up w/ ct indicated rct.Revision was recommended to convert to rtsa.Patient delayed surgery for over a year.Intra-op findings showed an intact rc.Significant synovitis was encountered, and a deep infection was suspected.A stage revision was carried out by placing a spacer.The outcome of this event is considered resolved on (b)(6) 2024.The action taken was revision on with the removal of the standard humeral stem, replicator plate, torque screw, humeral head, glenoid.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
A review of the sterile certificates and the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.B3: corrected.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: 18861547
• Report Number: 1038671-2024-00432
• Device Sequence Number: 8282568
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 300-01-13
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2018
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White