MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-00

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

Patient Problem Failure of Implant (1924)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that an 89 yo male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 5 months post the initial procedure.The patient presented with pain.The shoulder was opened to investigate.Frank pus was found in the joint.All implants were removed and a cement spacer was placed in situ to treat the infection.There were no surgical delays or device breakages during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No device returns for analysis anticipated.The devices were sent to a lab for independent testing.Device images were provided.

Manufacturer Narrative

H3: pending investigation.D10: a591741 - 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.A496845 - 315-35-00 - glnd kwire.A375272 - 320-01-38 - equinoxe reverse 38mm glenosphere a649446 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 6652890 - 320-15-02 - rs glenoid plate sup aug, 10 deg a609952 - 320-15-05 - eq rev locking screw a588953 - 320-20-00 - eq reverse torque defining screw kit a562816 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s457712 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s457212 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm a027220 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.

Manufacturer Narrative

H3: the revision reported was likely the result of infection.The cause of surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The wear noted on the explanted humeral liner is likely the result of impingement with the scapula secondary to a malpositioned glenoid baseplate.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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: 19084294
• MDR Text Key: 339878652
• Report Number: 1038671-2024-00785
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2023
• 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 Sex: Male