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

Catalog Number 314-13-13

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2023

Event Type  Injury  

Event Description

As reported, approximately 5 years post op the initial tsa, this 56 y/o male patient was revised due to metallosis.

Manufacturer Narrative

Pending manufacturer evaluation.Concomitant device(s): equinoxe, humeral stem primary, press fit 13mm, category #: 300-01-13, serial #: (b)(4), equinoxe, humeral head short, 47mm (beta, category #: 310-01-47, serial #: (b)(4), equinox square torque define screw drive kit, category #: 300-20-02, serial #: (b)(4), equinoxe replicator plate 1.5mm o/s, category #: 300-10-15, serial #: (b)(4).

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of the center cage detaching from the polyethylene body possibly as a result of off-axis drilling and/or incomplete seating of the cage glenoid during implantation.The incomplete seating may have allowed for the center cage to punch through the polyethylene body leading to metal-on-metal contact between the center cage and the humeral head.However, this cannot be confirmed because the components were not returned for evaluation.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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: 16478967
• MDR Text Key: 310616121
• Report Number: 1038671-2023-00345
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Male