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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: serial number, item number, and full description.(b)(6), 320-15-02, - rs glenoid plate sup aug, 10 deg.(b)(6), 300-01-15, - equinoxe, humeral stem primary, press fit 15mm.(b)(6), 320-10-00, - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-01-42, - equinoxe reverse 42mm glenosphere.

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2017.The patient presented had multiple patient-reported dislocations over 3 year period, no trauma.None documented with x-ray.Always able to self reduce.The case report form indicates that this event is possibly related to device, possibly related to procedure.Outcome: continuing.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17718327
• MDR Text Key: 323039944
• Report Number: 1038671-2023-02222
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/09/2022
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2017
• 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 Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White