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

Catalog Number 320-01-38

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

Patient Problem Failure of Implant (1924)

Event Date 02/26/2024

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2023.It appeared the glenosphere had loosened/not been implanted properly.Wear evidences shown on liner and humerus.The patient was revised on (b)(6) 2024.Everything was removed and a new reverse shoulder was implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

H3: pending investigation.D10: (b)(6) - 300-30-08 - equinoxe preserve stem 8mm.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 320-38-00 - equinoxe reverse 38mm humeral liner +0 a727003 - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-15-01 - eq rev glenoid plate.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit s457020 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(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) - 320-38-00 - equinoxe reverse 38mm humeral liner +0 a585721 - 321-52-07 - 3.2mm drill bit sterile.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18939285
• MDR Text Key: 338073383
• Report Number: 1038671-2024-00585
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male