MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, LEFT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 314-13-24

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2022

Event Type  Injury  

Event Description

As reported, approximately 3 years post op the initial left tsa, this 79 y/o male patient was revised.The patient presented with shoulder pain.Upon x-ray it was determined that the poly implant had disassociated from the titanium pegs.The surgeon decided to remove the anatomic prosthesis and convert to a reverse as the patient had now developed rotator cuff arthropathy.All items were successfully removed, and the patient received a well fixed reverse prosthesis.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Devices are not returning.

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.Concomitant medical products: (b)(4), 201-78-89 - 3 drill bit, mod.Hex 2 pack.(b)(4), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(4), 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(4), 300-20-02 - equinox square torque define screw drive kit.(b)(4), 310-01-50 - equinoxe, humeral head short, 50mm (beta).(b)(4), 314-13-24 - equinoxe cage glenoid l, post aug, left.(b)(4), 315-35-00 - glnd kwire.(b)(4), 315-35-00 - glnd kwire.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of disassociation of the center cage and 2 of 3 peripheral pegs of the cage glenoid.The cause of the center cage/peg disassociation cannot be determined from the information provided but may have occurred due to incomplete drilling or seating of the pegs/cage during implantation.The exact events and order of events cannot be determined because no other x-rays were provided, such as original post-operative and follow-up views, and the revised components were not returned to exactech for evaluation.The following sections have corrected information: (h6) component code: 4315, cause not established.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16077015
• MDR Text Key: 306407996
• Report Number: 1038671-2022-01650
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Model Number: 314-13-24
• Device Catalogue Number: 314-13-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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: 79 YR
• Patient Sex: Male