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 Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: a606491 - 320-01-38 - equinoxe reverse 38mm glenosphere.A742326 - 320-15-05 - eq rev locking screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 70 yo male patient, initially implanted on (b)(6) 2017, who had a revision procedure on (b)(6) 2023, underwent a 2nd revision procedure on (b)(6) 2024, approximately 2 months post the first revision procedure.The patient was revised due to infection.They were revised to exactech¿s devices.They were opened and washed out.No x-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices available for analysis.They were disposed of by the hospital.No device images were available.No other patient information/medical history reported.First revision reported under: (b)(4).

• 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 ; 3523782617
• MDR Report Key: 18853158
• MDR Text Key: 337069510
• Report Number: 1038671-2024-00421
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/11/2024
• Initial Date FDA Received: 03/06/2024
• Date Device Manufactured: 05/23/2023
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male