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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6), 304-22-09 - 8.5mm platform fx stem right.(b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), tpa-18 - cement restrictor small.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 67 yo female patient, initial right shoulder implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2023, approximately 8 years post the initial procedure.The patient had limited rom and pain.The surgeon stated the stem was very anteverted.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.No device returns anticipated for analysis due to the hospital policy.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: 17924094
• MDR Text Key: 325527734
• Report Number: 1038671-2023-02521
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Date Device Manufactured: 08/11/2015
• 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: 67 YR
• Patient Sex: Female