MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-13

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

7033170 - 300-30-11 - equinoxe preserve stem 11mm a149071 - 320-06-42 - glenosphere 42mm a135617 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 a163013 - 320-15-05 - eq rev locking screw 6144875 - 320-15-07 - sup/post aug plate, l rs glenoid baseplate a124848 320-20-00 - eq reverse torque defining screw kit a166821 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm a039019 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm a141012 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm 6029281 - 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm 6097913 - 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm s336228 - 320-42-00 - 145-deg pe 42mm hum liner +0 (b)(6) - 320-42-13 - 145-deg pe 42mm const hum liner +2.5.

Event Description

It was reported that a 81 yo male patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2024, approximately 1 year 5 months post the initial procedure.The patient presented with complaints of pain.Bad poly indicated.The poly was replaced.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.The explanted device is not available for return.Chain of command, due to the recall the hospital will not release it.A device image was provided.No further information.No other patient information/medical history reported.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153302
• MDR Text Key: 340721032
• Report Number: 1038671-2024-00920
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• 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: 04/22/2024

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 Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• 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 10
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 81 KG