MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-02-42 - rs expanded glenosphere 42mm, +4mm offset: 6528876.320-10-05 - equinoxe reverse tray adapter plate tray +5: 6429883.320-15-05 - eq rev locking screw: 6520143.320-20-00 - eq reverse torque defining screw kit: 6486713.321-20-00 - equinoxe reverse shoulder drill kit: 6525408.(h3) pending evaluation.
Event or Problem Description
Study: equinoxe shoulder study.Subject: (b)(4).Related to: case: (b)(4).Implant date: on (b)(6) 2020.Ex-plant date: on (b)(6) 2020.Date of event onset: 08-05-2020.Adverse event name : superficial infection.Serious adverse event? yes.Ae related to device? definitely not related.Ae related to procedure? possibly related.Action taken: revision - standard reverse w-preserve stem, other - irrigation and debridement scheduled for on (b)(6) 2020.Revision date: on (b)(6) 2020.Outcome: resolved.P/n: 320-42-13.Device name: equinoxe reverse 42mm humeral const liner +2.5.S/n: (b)(6) confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k063569.Udi: (b)(4).Product code: kwt.Concomitants: 320-02-42 - rs expanded glenosphere 42mm, +4mm offset: 6528876.320-10-05 - equinoxe reverse tray adapter plate tray +5: 6429883.320-15-05 - eq rev locking screw : 6520143.320-20-00 - eq reverse torque defining screw kit: 6486713.321-20-00 - equinoxe reverse shoulder drill kit: 6525408.69-year-old white male.Height: 72 in.Bmi: 30.Previous surgery on involved shoulder? yes - 1999- open rotator cuff repair, on (b)(6) 2018- reverse shoulder arthroplasty.Diagnosis: other - dissociated polyethylene component, recurrent instability episodes comorbidities: hypertension, other - hypothyroidism, hypercholesterolemia unspecified analgesic use.This event report was received through clinical data collection activities and no device return is anticipated.Ebi implantation surgery results attached.Historical records, smart solve, and inbox searched for duplicate cases by serial numbers and/or clinical trial subject with no results.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.Additionally, infection is a known surgical risk, as outlined in the ifu.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 42MM HUMERAL CONST LINER +2.5
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19048164
• Report Number: 1038671-2024-00745
• Device Sequence Number: 20969487
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Expiration Date: 08/27/2024
• Device Catalogue Number: 320-42-13
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2019
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White