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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/05/2020

Event Type  Injury  

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 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.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• Type of Device: 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
• MDR Text Key: 339435222
• Report Number: 1038671-2024-00745
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White