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 Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/08/2021

Event Type  Injury  

Event Description

As reported by clinical shoulder study, the patient had a right tsa on (b)(6) 2020.The patient presented to the clinic on (b)(6) 2020 with increased pain after being overextended in physical therapy.Ct scan showed glenoid loosening.The patient was revised on (b)(6) 2020.

Manufacturer Narrative

H3: pending investigation.D10: 6313744: 300-01-14 - equinoxe humeral stem primary press fit 14mm, 6513571: 320-10-00 - equinoxe reverse tray adapter plate tray +0 , 6509206: 320-02-38 - rs expanded glenosphere 38mm, +4mm offset , 6516750: 320-38-00 - equinoxe reverse 38mm humeral liner +0.

• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18692358
• MDR Text Key: 335185737
• Report Number: 1038671-2024-00206
• Device Sequence Number: 1
• Product Code: KWT
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White