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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Laxity (4526)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4979963 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, 4987955 320-01-42 - equinoxe reverse 42mm glenosphere, 5149241 320-10-00 - equinoxe reverse tray adapter plate tray +0, 5160950 315-35-00 - glnd kwire, 5172286 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, 5190906 320-15-05 - eq rev locking screw, 5235420 300-01-15 - equinoxe, humeral stem primary, press fit 15mm, 5249988 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, 5250101 320-20-00 - eq reverse torque defining screw kit, 5254802 320-15-01 - eq rev glenoid plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 71 yo male patient, initial right shoulder implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2023.The patient had an unstable shoulder.The poly was increased to tighten up the shoulder.The reported information indicated that there was no failure of the shoulder components, the patient¿s shoulder loosened up post-surgery.There were no device breakage or surgical delays reported.The patient was last known to be in stable condition following the event.The device is not available for return.Reason unknown.No device images or x-rays were provided.No patient history provided.The report indicated that due to hippa compliance, the surgeon's office nor the hospital system will give patient information anymore.No further information.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16908163
• MDR Text Key: 314972835
• Report Number: 1038671-2023-00961
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Date Device Manufactured: 11/21/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male