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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +2.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 6734189 - 320-02-38 - rs expanded glenosphere 38mm, +4mm offset.7210419 - 320-10-10 - equinoxe reverse tray adapter plate tray +10.6259218 - 320-10-15 - humeral tray +15mm.7253808 - 320-15-05 - eq rev locking screw.7271419 - 320-20-00 - eq reverse torque defining screw kit.7271433 - 320-20-00 - eq reverse torque defining screw kit.S311116 - 320-38-00 - 145-deg pe 38mm hum liner +0.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 62 yo male patient, who had an initial rtsa on (b)(6) 2020, and had a revision procedure on (b)(6) 2022, underwent a 2nd revision procedure on (b)(6) 2024, approximately 1 year 11 months post the first revision in (b)(6) 2022.The patient did very well for about 2 years, until he recently dislocated, causing this revision.The patient was revised to a 42mm +4mm glenosphere, new locking screw, +0mm 38mm constrained liner, +15mm tray and new reverse torque screw.Fiber tape cerclage was also used around proximal humerus and tray.There were no device breakages during the procedure.There was a 30-45 minute surgical delay during the procedure with no adverse event to the patient as a result.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.No explanted devices are available for analysis as the hospital is keeping the devices.A device image was provided.No further information.The (b)(6) 2022 revision procedure was reported under mdr #1038671-2024-00546.

• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927418
• MDR Text Key: 337944758
• Report Number: 1038671-2024-00550
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male