MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/21/2021

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 62-year-old male patient had a right tsa on (b)(6) 2020.The patient presented with a dislocation on (b)(6) 2021.Patient had spine surgery on (b)(6) 2021 & has had shoulder pain since.Physical therapy was ordered for strengthening exercises.Shoulder became easily aggravated, so ct was ordered.Ct completed on 1-6-2022 showing dislocation.Pt came to office visit on (b)(6) 2022, x-rays done confirming dislocation w/ possible dissociation of polyethylene liner from humeral tray.Revision done on (b)(6) 2022.This event is related to (b)(4).The outcome of this event is considered resolved by the action taken of standard reverse revision on (b)(6) 2022.The case report form indicates that this event is definitely not related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm: 6597110.315-35-00 - glnd kwire: 6670534.315-35-00 - glnd kwire: 6685298.320-06-38 - glenosphere 38mm: 6581847.320-10-00 - equinoxe reverse tray adapter plate tray +0: 6676606.320-15-04 - rs glenoid plate r post aug, 8 deg, right: 5276547.320-15-05 - eq rev locking screw: 6666160.320-20-00 - eq reverse torque defining screw kit: 6692148.320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: (b)(6).321-20-00 - equinoxe reverse shoulder drill kit: 6650736.(h3) pending evaluation.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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: michael crader ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18972965
• MDR Text Key: 338549849
• Report Number: 1038671-2024-00658
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2020
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White