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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 300-30-12 - equinoxe preserve stem 12mm, (b)(6).320-06-42 - glenosphere 42mm, (b)(6).320-10-15 - humeral tray +15mm, (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, (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that an 80 yo male patient, initial right shoulder implanted, (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 8 months post the initial procedure.The patient complained of pain.The implant disassociated.The liner was replaced.There were no surgical delays or device breakages reported.Patient was last known to be in stable condition following the event.Product is not being returned due to the hospital is unable to release without patient approval.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: 17388670
• MDR Text Key: 319669925
• Report Number: 1038671-2023-01759
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 07/07/2023
• Date Device Manufactured: 08/09/2022
• 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: 80 YR
• Patient Sex: Male